SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identi
FDA device recall Z-1045-2012 · posted 2012-02-16 · Terminated
Recall details
- Recalling firm
- bioMerieux, Inc.
- Reason for recall
- Reports of false negative results in organism identification.
- Action taken
- Biomerieux sent an "URGENT PRODUCT REMOVAL NOTICE" dated December 21, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter instructs the customer to stop using and to destroy the affected products. The firm recommends steps to follow when interpreting results. An acknowledgement and Product Replacement Form was enclosed for the customer to complete and return to the firm. Contact Biomerieux Customer Service representative at (800) 682-2666 for information regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWX
- Quantity affected
- 100 kits
- Distribution
- Distributed to one customer in California.
- Date initiated
- 2011-12-21
- Date posted
- 2012-02-16
- Date terminated
- 2013-09-17
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SLIDEX STAPH-KIT (K923212) | Biomerieux Vitek, Inc. | 1992-09-28 |