Recall Z-1045-2012 ยท JWX Kit, Screening, Staphylococcus Aureus
bioMerieux, Inc.
SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.
| Date | Feb 16, 2012 (initiated Dec 21, 2011) |
| Status | Terminated |
| Reason | Reports of false negative results in organism identification. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 100 kits |
| Distribution | Distributed to one customer in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923212 | SLIDEX STAPH-KIT Biomerieux Vitek, Inc., Sep 28, 1992 |