bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card Cefotoxin and AST for Oxacillin bioMerieux VITEK 2 AST-P631 bioMerieux VITEK 2 AST-GP67 Test Kit bioMerieux VITEK 2 AST-GP71 Test Kit bioMerieux VITEK 2 AST-GP75 Test
Check against the official notice below — it lists the full affected range.
bioMerieux, Inc. is recalling multiple VITEK 2 diagnostic test products used to detect antibiotic resistance in gram-positive bacteria. The products affected include the VITEK 2 AST-P631 and several VITEK 2 AST test kits (GP67, GP71, GP75, and GP78) that contain cards testing for oxacillin and cefoxitin susceptibility. Customer reports identified an increase in the rate of non-detected MRSA (methicillin-resistant Staphylococcus aureus) associated with these products. Approximately 13,961,320 units have been distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries across the Americas, Europe, Asia, Africa, and Oceania.
The recall affects all lots of the specified product reference numbers and their corresponding universal device identifiers. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
Reason for recall: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. Distribution: Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar, Nicaragua, Peru, Philippines, Paraguay, Singapore, Thailand, El Salvador, and Vietnam. Quantity: 13,961,320 US Lot/code info: VITEK 2 AST-P631, Ref # 414961 UDI 03573026426804 OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin OX, OXSF, multiple Gram Positive Cards all lots of cards with Oxacillin and Cefotoxin VITEK 2 AST-GP67 Test Kit, Ref: # 22226 UDI 03573026242060, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP71 Test Kit, Ref: #410750 UDI 03573026355173, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP75 Test Kit, Ref: #415670 UDI 03573026437183, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin. VITEK 2 AST-GP78 Test Kit, Ref: #421051 UDI 03573026553982, OX, OXSF, multiple Gram Positive Cards, all lots of cards with Oxacillin and Cefotoxin.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.