Diagnostica Stago, Inc. Recalls
Showing 1-20 of 22 recalls
STA UNICALIBRATOR (ref. 00675)
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: FIELD SAFETY NOTICE Combined use of the following reagents STA UNICALIBRATOR (ref. 00675) and STA DEFICIENT VIII (ref. 00725) STA DEFICIENT IX (ref. 00724) Dear Customer, You are using the STA Unicalibrator (00675) and STA Deficient VIII (00725) and/or STA Deficient IX (00724) and according to our records, you have ordered and received in your laboratory one or several kits of the STA - Unicalibrator listed in Appendix 1. Following the identification of a defect, please see the information below about the reagents and lots listed in Appendix 1. Description: Following a customer complaint, Stago has investigated and confirmed a positive bias on some STA - Unicalibrator levels. These high levels affect tests using STA - Deficient IX and STA - Deficient VIII reagents. Stago has accordingly reduced the concerned Unicalibrator plasma levels (see new levels on the attached lot-specific barcode sheets). According to our internal testing results, the reduced Unicalibrator plasma levels result in a decrease of Factor VIII and IX results on normal and below-normal patient plasmas. This change has no impact on the classification of hemophiliac patients (type A or B) as severe, moderate or mild. The reassignment of the Unicalibrator plasma levels necessitated a change in the acceptance ranges on the corresponding Quality Control plasmas for Factor VIII and IX parameters with the STA - Deficient VIII and IX reagents. You will find new barcode sheets for each lot of the affected reagents in the attachments. Actions: Upon receipt of this letter, we kindly ask you to: - No longer use the values indicated for STA - Deficient VIII and IX reagents on the barcode sheets in your possession (for the reagents & lots listed in Appendix 1). - Use the new barcode sheets (attached): - For STA - Unicalibrator: Use the analyzer-spec
STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979
A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
Stago notified on 3/4/20 end users of the risks to factor VIII tests in writing. Letters issued via email, US mail, and/or UPS overnight mail. Letter states reason for recall, health risk and action to take: To remove this cross-contamination risk, a special pre-wash has been developed for the concerned Stago methodology. It involves special washing of needle 1 before every factor VIII assay in order to eliminate any residual quantities of Emicizumab. This cleaning sequence has been implemented in the stated available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel. Completed enclosed acknowledgement coupon to Stago confirming you have read the letter and will apply the instructions Please fax to 1-973-644-9348 or e-mail toquality.systems@us.stago.com. For additional information, please contact your Stago Hotline at 1-800-725-0607. In addition- Since the Stago analyzer platforms are open systems, analyzer customers may be performing other factor VIII assays (e.g. LDTs, or other manufacturers factor VIII products) that Stago has no visibility to, or control over. Therefore an Information Letter issued to all other US customers of the analyzers, to alert customers to the risk that factor VIII testing on these Stago analyzers can be affected by the Emicizumab molecule, and to contact technical service teams for assistance.
Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
The firm, STAGO, sent a "Field Safety Notice" to its customers on 11/14/18. The notices describe the product, problem and actions to be taken. The customers were instructed to do the following: If you have any lots listed in the appendix in your laboratory, stop using and destroy the concerned kits; contact our sales administration team (1-800-222-2624 prompt #3) as soon as possible in order to obtain a replacement lot and complete the attached coupon acknowledging receipt of the letter. For additional information, please contact the STAGO hotline (1-800-725-0607) or email: Donald.kraft@us.stago.com or 1-973-631-1200 ext 4104.
Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875).
QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
Diagnostica Stago issued notification on July 24, 2018 to US Customers provided the reason for the notification, actions to be taken to mitigate the risk. Action: If you have in your laboratory, any of the lots among those listed in the appendix, we are asking you to: If it is not already done, run a Quality Control test at every change of vial. Return to your Stago affiliate, by fax or e-mail, the enclosed form completed and confirming that you have read this letter. Questions contact Stago Hotline (1-800-725-0607)
Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
Diagnostica Stago sent a "Quality Information" letter/Customer Acknowledgement form to its customers. The letter identified the product, problem, and actions to be taken by the customers. For additional information and further support contact the Diagnostica Stago Hotline at 800-725-0607.
STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STAbrand name suitable to these reagents: -the Reagent 1 (STA-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase time, factors II, V, VII, VIII, IX, X, XI and XII
Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.
Stago sent a recall letters via email dated August 23, 2011 to all affected customers . The letter identified the product, description of problem, and corrective actions to be taken. Customers were asked to immediately examine their inventory and follow the corrective actions provided. Customers were instructed to complete the response form attached to the letter. Because of incorrect manufacturer's instructions included in the initial letter another letter was emailed by the firm on August 30, 2011. For questions or technical assistance for updating the parameters please call the Diagnostica Stago 24 hour hotline at 1-800-725-0607.
Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Diagnostica Stago Inc. sent e-mail notifications on 1/28/2013 to all consignees (laboratory supervisor). The written field safety notice, entitled Important Field Safety Notice, with its response form was attached. The letter identified the affected product and gave a description of the defect. Customers were asked to confirm all the results obtained in the abnormal range by either of the two methods provided. Users are to complete and return the enclosed response form as soon as possible to the Stago Hotline via fax, 973-644-9348. Questions should be directed to the Stago Hotline at 800-725-0607.
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite.
Diagnostica Stago sent an Urgent Field Safety Notice dated June 12, 2012, to all affected customers via email return receipt requested on June 15, 2012. Customers were instructed to follow the instructions in the notification and complete the Customer Verification form and return to the Hotline by fax to 973-644-9348. For additional information, customers were instructed to contact the Hotline at 800-725-0607. For questions regarding this recall call 973-631-1200, ext 2044.
STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C Distributed in the USA by: Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ Phone 800-abc coag 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex
Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
Customers were sent a Product Recall Notification on May 8, 2007 by first class mail labeled " Recall notice, Open Immediately"
STA Neoplastine CI 10; Product Catalogue Number: 0666; Manufactured by Diagnostica Stago, Asnieres, France.
Internal investigation has determined the potential lack of homogeneity between product vials.
Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail. The letter stated the reason for the notice, the corrective action, and replacement process. Customers are to confirm that they received the Recall Notice by completing the attached "Product Recall Response Form" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095. The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory. If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.
STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT).
Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.
Recall notification letters were sent on March 30, 2007 by first class mail. The letter advises customers that lot 061781 of STA-Neoplastine Cl Plus may cause difficulty during the vailidation process of STA-Coag Control ABN control plasmas, and asks that the lot number be discontinued.
STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor.
A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.
Customers were notified on March 13, 2007 by letter, first class mail.
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.
Recall notification letters were mailed to consignees on 7/30/07 by first class mail.
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
A recall notification has not been sent. The firm did issue a technical bulletin to their representatives.--Update: based on FDA input the firm issued a Recall Letter to all users dated May 25, 2007
Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
Recall notification letters were sent out via first class mail on July 18, 2006.
PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method.
The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
Notification via recall letter was sent out on 10/26/2005. The letter was unsatisfactory and the letter was resent on 11/10/2005 as a recall letter.
STA-R blood coagulation analyzer. Catalog Number 57160.
Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.
FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distri
The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.
Diagnostica Stago sent a letter dated 12/4/2002 along with effectiveness check form to all customers.