—#165899

Product

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 Kit bioMerieux VITEK 2 AST-GP78 Test Kit Components for an automated invitro diagnostic system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

FDA product code: LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K053097
Affected 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.

Why it was recalled

Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

bioMerieux sent an Urgent Product Correction Notice letter to their French customers on January 26, 2018. Customer letters in the Americas were sent August 21, 2018. The letters identified the affected product, problem, and actions to be taken. Customers should follow steps outlined in the letter and contact bioMerieux for any additional questions regarding these corrective actions. Note: the actions do not include removal of the product. For any questions or concerns, contact your local bioMerieux representative.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2018-01-26
Posted by FDA: 2018-08-30
Terminated: 2019-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165899. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.