Qiagen Sciences LLC Recalls
Showing 1-14 of 14 recalls
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to serious medical consequences such as the suspension or non-initiation of treatment
QIAGEN issued Urgent Medical Device Correction via email on 1/28/20 advising reason for recall, health risk and action to take: 1) Discontinue use of the Rotor-Gene Q instrument in the following specific conditions: The Rotor-Gene Q instrument is running Software 2.3.4 using the export function to LIMs 2) Upgrade to the latest version of the RGQ software which resolves the issue version 2.3.5. This is expected to be available on 1st February 2020. Please visit the QIAGEN website to upgrade: www.qiagen.com/resources/resourcedetail?id=9d8bda8e-1fd7-4519-a1ff-b60bba526b57&lang=en. Apart from correcting this fault, no other changes to the software have been implemented. Laboratory personnel and clinicians are advised to consider a patients previous test results, other diagnostic tests, anamnesis and current clinical condition when interpreting results from this software. If the results do not match the patients clinical presentation, or incongruences are found with previous and concomitant tests or the results are otherwise unexpected, the patient sample should be retested using an alternate test method or a reference laboratory. 3) Complete the Acknowledgement of Receipt form and return it to QIAGEN. If you have further questions, please contact QIAGEN Technical Services Department on 800-362-7737 (US & Canada) " QIAGEN Subsidiaries: https://www.qiagen.com/about-us/contact/global-contacts/subsidiaries/ " QIAGEN Commercial Partners and Importers: https://www.qiagen.com/about-us/contact/global-contacts/distributors-and-importers/
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
On November 8, 2021, the firm began notifying customers. Customers received an Urgent Medical Device Correction Notice via email. Customers were instructed to do the following: - Please check the cartridge SNs received from LOT 210209 against the list of affected cartridges shown in Table 1 (page 1). If you have received one of the affected cartridges, please contact QIAGEN Technical Service for a free-of-charge replacement. - If you have received one of the 16 affected cartridges and have not used it, please dispose of it immediately in accordance with your national and local safety and environmental regulations. - If you already used one of the affected cartridges from this LOT, please identify the results obtained with the affected SNs listed on Table 1 (page 1). For results obtained with an affected SN, review the results as follows: o Review all results of the respective targets mentioned on page 1 to exclude erroneous diagnosis and treatment, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed on clinical and/or epidemiological suspicion of the respective targets. - If you have remaining stocks from LOT 210209, cat. no 691223 with cartridge SNs not found in the list, you may still use these cartridges, as this issue is limited to the 16 cartridges listed on Table 1 (page 1). - Review this notice with your laboratory/medical director. - IMPORTANT: Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. - Complete the Acknowledgement of Receipt attached to the letter by November 22, 2021. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
QIAcube Connect MDx, Model No. 9003070
During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.
Customers were notified of the initial issue by email beginning Nov 3 2021, and requested to return acknowledgment of the notice. On January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice.
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
Qiagen issued July 20,2022 letter ( REF 874721) via email (A) US customers: notify customers by Urgent Medical Device Correction Letter; (B) CE customers: notify customers by Urgent Field Safety Notice (C) RUO (not IVD) customers: notify customers by Important Notice. Letter states reason for recall, health risk and action to take: For the continued use of REF 874721 therascreen FGFR RGQ RT-PCR Kit LOT 172017274 , please note the following criteria: Samples with the Overall sample result No Alteration Detected should be regarded as correct and no further actions are needed. Samples with the FGFR Alteration Detected results with Individual target result S249C Mutation Detected can be regarded as correct. This also includes samples with additional alterations detected. All other FGFR Alteration Detected results aside from S249C Mutation Detected should be disregarded and a retest for confirmatory positive result should be performed using the extracted RNA if available, or re-extracted if it is not. The following results should be assigned to the affected samples after the retest: l Retest result is positive for the same target(s)/ alteration(s): regard the result for the corresponding sample as positive. l Retest result is positive for different target(s)/ alteration(s) in the retest compared to the initial result: regard the result as indeterminate. l Retest is negative: the result for the corresponding sample should be regarded as negative l Retested sample is within an invalid run: repeat the run. l Result for individual sample is invalid in the retest: regard the result as indeterminate Forward this information to all individuals and departments within your organization who are using REF 874721 therascreen FGFR RGQ RT-PCR Kit. l If you are not the end user, please forward this notice to the product end user. l Review this notice with your laboratory/medical director. l Complete the Acknowledgement of Receipt Form attached to this letter by 28 July
SARS-CoV-2 Antigen Test
QIAGEN has become aware of the potential for false positive results to occur with some patient samples.
On 01/13/2021, Qiagen issued Urgent Medical Device Correction notices to customers via phone and email. Customers were advised to do the following stop using the product and return any remaining product back to Qiagen.
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.
Qiagen US notified customers by Urgent Medical Device Correction letter via e-mail on 12/11/20. The e-mail additionally contains the letter as PDF. Letter states reason for recall, health risk and action to take: For patient samples where a PIK3CA Mutation Detected Result is obtained, disregard Q546R positive results. Cease to report patient samples where a Q546R mutation result is obtained as PIK3CA Mutation Detected. Information about individual target results is specifically obtained from the Individual target result column of the Rotor-Gene Assay Manager v2.1 result table. If multiple mutations including Q546R are detected, disregard the Q546R result only. Continue to consider all other results as valid and report them accordingly. l For the purpose of run validity, Q546R control data must still be produced. The therascreen PIK3CA RGQ PCR Kit software requires valid run control data from the Q546R reaction for the overall test to be valid. Therefore, continue to use all supplied reagents and perform testing as described in the kit handbook, but disregard Q546R positive results generated for patient samples as described in the previous bullet points. l Forward this information to all individuals and departments within your organization who are using the therascreen PIK3CA RGQ PCR Kit REF 873121. If you are not the end-user, please forward this notice to the product end-user. l Review this notice with your laboratory/medical director. l Complete the Acknowledgement or Receipt Form attached to this letter by December 22, 2020 and email it to quality.communications@qiagen.com. QIAGEN is now revising the Instructions for Use for the therascreen PIK3CA RGQ PCR Kit, as described in this notice, to reduce any risk resulting from non-specific molecular interactions within the Q546R reaction leading to the generation of Q546R false mutation positive results. QIAGEN is also updating the therascreen PIK3CA FFPE and Plasma Assay Profile software packages to
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.
Qiagen issued Urgent Medical Device Correction therascreen KRAS RGQ PCR Kit (24), REF 870021 letter on 2/25/22. Letter states reason for recall, health risk and action to take: This notice is only relevant for the analysis of samples originating from non-small cell lung cancer (NSCLC) tissue. For continued use of the therascreen KRAS RGQ PCR Kit (24), check the Flags/Warnings in the Sample Result table for automated interpretation of results. Sample results with one or more of the Flags/Warnings listed in this notice should be regarded as invalid with respect to the KRAS status and KRAS Mutation status. Setup a new PCR run to repeat the affected sample(s). To minimize Flags/Warnings for the controls and samples, strict compliance to the IFU guidance should be followed, including but not limited to: Correct reagent mixing is required, and must be ensured at each mixing step during the assay setup. Placement of the Rotor-Gene Q MDx according to Installation Procedures site requirements Forward this information to all individuals and departments within your organization who are using the therascreen KRAS RGQ PCR Kit (24), REF. 870021. If you are not the end user, please forward this notice to the product end user. Review this notice with your laboratory/medical director. Complete the Acknowledgement of Receipt Form attached to this letter by March 10, 2022 and email it to quality.communications@qiagen.com. QIAGEN is revising the Instructions for Use, as described in this notice, to reduce any risk resulting from the calling of a false positive or false negative G12C (12CYS) mutation result for NSCLC samples due to the Flags/Warnings listed in this notice and to emphasize strict compliance to the IFU guidance to minimize Flags/Warning. If you have any questions or concerns, pleas.se contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
There is a risk for a false mutation positive result in rare cases resulting from a fluorescence artefact. In these rare cases, the controls pass correctly, while a fluorescence artefact in the mutation assay causes an incorrect valid mutation positive result.
Urgent Medical Device Correction notification letters dated 4/8/20 were sent to customers. Actions to be taken by the customer: For continued use of the therascreen EGFR RGQ PCR Kit (24), check the delta CT values (CT) in the sample result table for automated interpretation of results. For mutation positive results with a CT below -10.00, these should be considered invalid and retested. To implement the new cutoff for the delta CT (CT), the following new instruction replaces the Table 12 (p.46) of the therascreen EGFR RGQ PCR Kit Handbook. If you have concerns about previously generated mutation positive results with the therascreen EGFR RGQ PCR Kit (24), REF. 870121, the criteria listed above can be used for review. The mixing step described in the DNA sample assessment protocol (page 25, step 8) of the therascreen EGFR RGQ PCR Handbook dated October 2019 should also be performed after step 10 on page 36 of the mutation detection protocol. To obtain a valid qPCR result for the controls and samples, strict attention must be paid to thorough reagent mixing at each mixing step during the assay setup in accordance to the instructions for use. Forward this information to all individuals and departments within your organization who are using the therascreen EGFR RGQ PCR Kit (24), REF. 870121. If you are not the end user, please forward this notice to the product end user. Review this notice with your laboratory/medical director. Complete the Acknowledgement of Receipt form attached to this letter by April 24, 2020 and email it to quality.communications@qiagen.com. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com Actions taken by QIAGEN QIAGEN is revising the instructions for use as described in this notice to reduce any risk resulting from fluorescence artefacts leading to invalid runs or fals
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
On July 15, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers to inform them of the increased rate of potential false positive results for the Influenza A (no subtype) target. Customers were instructed to do the following: l -Please review and reassess all Influenza A (no subtype) positive samples tested with the affected lots. -Please note that as per Instructions for Use if only an Influenza A signal is present and no additional signal for any of the subtypes is generated, it can be due to either low concentration or, in very rare cases, a new variant or any Influenza A strain other than H1 and H3 (e.g., H5N1, which can infect humans). Such result should, therefore, be interpreted in the context of epidemiological and clinical plausibility. -If you have used the affected lot/s and you have concerns about previously generated Influenza A (no subtype) positive results on the basis of which patient treatment/management was initiated, we recommend a review of the corresponding Influenza A (no subtype) positive results. -For continued use of the affected QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 LOTs, Flu A (no subtype) positive results should be retested with an alternate method and interpreted in the context of current epidemiology and clinical presentation. -Review this notice with your laboratory/medical director. -IMPORTANT: Forward this information to all individuals and departments within your organization using the above listed kits. If you are not the end user, please forward this notice to the product end user. -Please complete Acknowledgement of Receipt attached to this letter by 29 July 2020. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
On February 21, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the incorrect rinse time on the product's labeling, and reminded of the correct rinse time of 1 (one) minute. Customers were asked to immediately share the contents of the customer letter with all users of the AmniSure ROM Test in their facility to ensure awareness. Test users should refer to the instructions for use (IFU) included in each kit box. The firm is not asking for product to be returned. Customers were asked to complete and return an attached response form.
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
QIAGEN issued Urgent Device Notification dated June 5, 2019 stating problem, health risk and action to take: Forward this information to all individuals and departments who are using the above listed kit within your organization. If you are not the end user, please forward this notice to the product end user. If you have any remaining stocks of Filter-Tips, 1500 l (1024) REF 997024, lots 0605020019 and 0605020020, DO NOT USE them. For a free-of-charge replacement, please contact QIAGEN Technical Service. Dispose of the product in accordance with your national and local safety and environmental regulations. l Review this notice with your laboratory/medical director. l If you have used the affected kits with lots 0605020019 and/or 0605020020, we recommend a review of the corresponding results. l Complete the Acknowledgement of Receipt form attached to this letter by June 12, 2019 and email it to quality.communications@qiagen.com. Questions or concerns, contact your local QIAGEN Technical Service Department through any of the following: Telephone: 800 362 7737 Email: TechService-NA@qiagen.com
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of th
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
The firm sent an Urgent Notice of Product Field Action letters dated July 23, 2018 to customers. The letter identified the affected product, problem and actions to be taken by the customer/user/commercial partner in order to assure that your instrument is currently functioning properly. Customers were asked to complete and sign the included Acknowledgement of Receipt form and either email it to QIAGEN Technical Service at Techservice-eu@qiagen.com or fax it to +49 (0)2103-29-22400. For questions contact your local QIAGEN Technical Services Department.
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended
QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting
Qiagen notified Customer on July 2, 2019 via email and provided reason for recall, heath risk and action to take: Discontinue use of the workflow in the following specific condition: QIAsymphony software version 5.0.3 when using the 2D bar code integration feature with continuous loading. Please note that the 2D bar code labware, continuous loading, and Software 5.0.3 can still be used independently of the integration feature. Complete and sign the included Acknowledgement of Receipt form and email it to QIAGEN Technical Services at techservice-eu@qiagen.com or fax it to +49 (0)2103-29-22400. Questions, please contact QIAGEN Technical Services Department. Telephone: 800 362 7737. Email: TechService-NA@qiagen.com
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.