Recall Z-1110-2010
NERL Diagnostics Corporation · initiated January 15, 2010
Product
Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
Codes / lots: Lot Number: 1009029 Expiration Date: 06-2012
Reason for recall
Unreactive Staph latex reagent
FDA-determined cause: Process control
Action taken
NERL Diagnostics notified distributors on January 15, 2010, by letter to advise of the recall and request they examine inventory, discontinue use of affected lot numbers and discard any remaining inventory. In addition, if product was further distributed, notify the customers of the product recall. If you have any questions, please telephone 1-401-824-2046.
Details
- Recall number
- Z-1110-2010
- Initiated
- January 15, 2010
- Posted by FDA
- March 12, 2010
- Terminated
- October 5, 2011
- Product code
- JWX – Kit, Screening, Staphylococcus Aureus
- Quantity
- 125 kits
- Distribution
- NJ
- Recalling firm
- NERL Diagnostics Corporation, East Providence, RI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1111-2010 | Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog…Unreactive Staph latex reagent | 01/15/2010Terminated |