# FDA recall Z-2817-2018

> **bioMerieux, Inc.** · Class I · device recall initiated 2018-01-26.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2817-2018
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-08-29
- **Termination date:** 2019-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2817-2018

## Citation

> AI Analytics. FDA recall Z-2817-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2817-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*