Class 2 Device Recall Lifesign

• Date Initiated by Firm: January 15, 2010
• Date Posted: March 12, 2010
• Recall Status: Terminated on October 05, 2011
• Recall Number: Z-1110-2010
• Recall Event ID: 54267
• Product Classification: Kit, screening, staphylococcus aureus - Product Code JWX
• 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.
• Code Information: Lot Number: 1009029 Expiration Date: 06-2012
• Recalling Firm/ Manufacturer: NERL Diagnostics Corporation; 12 Almeida St; East Providence RI 02914-1002
• For Additional Information Contact: Tina L. Lombari; 401-824-2046
• Manufacturer Reason for Recall: Unreactive Staph latex reagent
• FDA Determined 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 in Commerce: 125 kits
• Distribution: NJ
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.