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U.S. Department of Health and Human Services

Class 2 Device Recall Lifesign

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  Class 2 Device Recall Lifesign see related information
Date Initiated by Firm January 15, 2010
Date Posted March 12, 2010
Recall Status1 Terminated 3 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 2
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.
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