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.
FDA Recall Z-1111-2010 · Posted 2010-03-12
Recalling FirmNERL Diagnostics Corporation
Recall StatusTerminated
Product CodeJWX
Date Initiated2010-01-15
Date Terminated2011-10-05
Product Quantity146 kits
Reason for Recall
Unreactive Staph latex reagent
Firm 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.
Root Cause
Process control
Distribution Pattern
NJ
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.