Recall Z-1111-2010 ยท JWX Kit, Screening, Staphylococcus Aureus
NERL Diagnostics Corporation
Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
| Date | Mar 12, 2010 (initiated Jan 15, 2010) |
| Status | Terminated |
| Reason | Unreactive Staph latex reagent |
| Root cause | Process control |
| Action | 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. |
| Quantity | 146 kits |
| Distribution | NJ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.