bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK...
FDA Device Recall #Z-2817-2018 — Class I — January 26, 2018
Recall Summary
| Recall Number | Z-2817-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | January 26, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | bioMerieux, Inc. |
| Location | Durham, NC |
| Product Type | Devices |
| 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.
Lot / 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.
Other Recalls from bioMerieux, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2671-2025 | Class II | VITEK¿ 2 Gram-negative AST Test Kits (Cards) co... | Jun 26, 2025 |
| Z-1564-2022 | Class II | NUCLISENS easyMAG Magnetic Silica, REF 280133, ... | Jul 20, 2022 |
| Z-1640-2022 | Class II | VITEK 2 / MYLA VITEK 2 Software versions 8.0... | Jul 13, 2022 |
| Z-1059-2022 | Class II | VITEK 2 Systems and VITEK 2 with MYLA. | Mar 29, 2022 |
| Z-0742-2022 | Class II | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. | Feb 9, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.