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Terminated

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.

FDA Recall Z-1110-2010 · Posted 2010-03-12

Recalling FirmNERL Diagnostics Corporation
Recall StatusTerminated
Product CodeJWX
Date Initiated2010-01-15
Date Terminated2011-10-05
Product Quantity125 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.

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