Recall Z-1045-2012
bioMerieux, Inc. · initiated December 21, 2011
Product
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.
Codes / lots: Catalog #73113, Lot number: 1105104545
Reason for recall
Reports of false negative results in organism identification.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1045-2012
- Initiated
- December 21, 2011
- Posted by FDA
- February 16, 2012
- Terminated
- September 17, 2013
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Quantity
- 100 kits
- Distribution
- Distributed to one customer in California.
- Recalling firm
- bioMerieux, Inc., Durham, NC