Remel Inc Recalls
Showing 21-40 of 41 recalls
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
Thermo Fisher Scientific sent a Medical Device Recall letter dated October 29, 2014, to all affected customers. The letter notified customers that Remel, Inc., a part of Thermo Fisher Scientific, was voluntarily recalling the affected product. Customers were instructed to notify any personnel who need to be notified of the potential for false negative results. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14
A reagent within the test may return false negative results.
ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
A reagent contained within the product may return false negative results.
The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers.
Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.
Oxoid and Remel part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated November 20, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The letter asked customers to destroy the affected product, if any was found on hand. The letter also asked if the customer further distributed the product that they inform their downstream customers. A response form was included with the letter and the letter instructed customers to complete and return the response form to indicate they had received the notification and that they had complied with it. If you have any questions please contact our Technical Service Department at 800-255-6730 (US) or 913-888-0939 (International).
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
The recalling firm made phone calls to their customers beginning 6/11/14 with follow-up letters dated 6/12/14 being issued via regular mail requesting the affected product be destroyed. Additional customers were later identified and additional phone calls were made on 6/16/14 and recall letters dated 6/16/14 were issued via regular mail.
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.
The product may contain high levels of microbial contamination
Thermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Some of the discs may not be impregnated with the antibiotic.
ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed, customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.
Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Boxes labeled as CIP5 may contain cartridges of AMP5.
Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5. For questions regarding this recall call 913-895-4185.
remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of RapID Yeast Plus Reagent B. Product Usage: For the biochemical identification of medically important yeast and yeast-like organisms.
The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
Thermo Fisher Scientific sent a Medical Device Recall letter dated April 3, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm instructed customer to review their inventory for affected lot and discard the product. A Medical Device Recall Return Response was enclosed for the customer to indicate they understood the instructions and to report the amount of product they discarded. For questions call Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are
The product may give weak or false negative test results.
ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.
Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes
Cartridges may contain individual discs which were not impregnated with antibiotic.
ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questions regarding this recall call 913-895-4185.
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
The firm, ThermoFisher Scientific, sent a "MEDICAL DEVICE RECALL" letter dated February 20, 2013 to its customers via regular mail. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory for affected product lots; discard the affected product; notify any personnel who needs to be notified of the potential for a false negative indication when using the swab, and complete and return the attached Medical Device Recall Return Response Acknowledgment & Receipt Form via Fax to: Attn: Technical Service & Regulatory Affairs at 1-877-428-1924. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
remel Haemophilus Test Medium (Agar), 100mm plates, 10/pk, Ref. #R01503. The firm name on the label is Remel, Lenexa, KS. For use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
Organism strains may fail to consistently produce confluent growth
The firm, Remel, Inc., sent two "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letters one dated April 20, 2011 to: Microbiology Lab Supervisors and the second dated April 25, 2011 to:Distributors via regular mail. The letters described the product, problem and actions to be taken. The customers were instructed to to review their inventory for the listed product lot(s); discard all remaining units of the product lots; and complete and return the Product Inventory Checklist by May 9, 2011 regardless if they have affected product in the enclosed self-addressed, stamped envelope. The distributors were further instructed to notify their customers if they further distributed the product. If you have inquiries concerning this advisory, please contact our Technical Services Department at 800-255-6730 or 913-888-0939.
Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures dem
The product failed to prevent growth of methicillin-sensitive Staphylococcus aureus (MSSA)
Remel, Inc. sent an "IMPORTANT MEDICAL DEVICE PRODUCT RECALL NOTICE" letter, dated May 10, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory and discard all remaining product lots. Additionally, customers are to complete the Product Inventory Checklist and indicate whether or not they desire replacement of the product or credit. A self-addressed , stamped envelope was enclosed in the letter to use to return the checklist. Questions can be answered by contacting the Technical Services Department at 800-255-6730 or 913-888-0939.
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
The product may contain low level microbial contamination which could result in incorrect results.
ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.
Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usage: Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
The firm is recalling the products due to a potential for false negative test results.
Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents
The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt.
ThermoFisher sent an Important Medical Device Product Recall Notice dated August 17, 2012, to all affected customers. The letter identifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review results reported using this lot and consider restesting and/or seek approproiate expert advice. Customers were requested to destroy any remaining inventory of the affected lot and contact Customer Services or their local Oxoid supplier who will issue a replacement. Customer were asked to return the attached "Acknowledgement & Receipt Form by FAX to 1-877-428-1922 or 1-913-895-4190. Customers with questions were instructed to call the Technical Support Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.