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.
This recall has been terminated (originally issued February 16, 2012).
- Company
- Biomerieux, Inc.
- Recall Initiated
- December 21, 2011
- Posted
- February 16, 2012
- Terminated
- September 17, 2013
- Recall Number
- Z-1045-2012
- Quantity
- 100 kits
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Reports of false negative results in organism identification.
Distribution
Distributed to one customer in California.
Lot / Code Info
Catalog #73113, Lot number: 1105104545
Root 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.