bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Suscep
FDA device recall Z-2817-2018 · posted 2018-08-30 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 13,961,320 US
- 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 Ko
- Date initiated
- 2018-01-26
- Date posted
- 2018-08-30
- Date terminated
- 2019-05-20
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN (K053097) | bioMerieux, Inc. | 2005-12-14 |