Z-2817-2018 Class I Terminated
FDA device recall Z-2817-2018 was initiated by bioMerieux, Inc. on Jan 26, 2018 and is designated Class I. Reason for recall: Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. The recall status is terminated (terminated May 20, 2019). Affected quantity: 13,961,320 US.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jan 26, 2018
- Termination Date
- May 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,961,320 US
Product Description
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.
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 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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2817-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026