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U.S. Department of Health and Human Services

Class 2 Device Recall SLIDEX Staph kit

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  Class 2 Device Recall SLIDEX Staph kit see related information
Date Initiated by Firm December 21, 2011
Date Posted February 16, 2012
Recall Status1 Terminated 3 on September 17, 2013
Recall Number Z-1045-2012
Recall Event ID 60990
510(K)Number K923212  
Product Classification Kit, screening, staphylococcus aureus - Product Code JWX
Product SLIDEX Staph kit (250 Tests).

The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.
Code Information Catalog #73113, Lot number: 1105104545
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Benjamin Smith
314-731-8537
Manufacturer Reason
for Recall		 Reports of false negative results in organism identification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Biomerieux sent an "URGENT PRODUCT REMOVAL NOTICE" dated December 21, 2011 to the affected customer. The letter describes the product, problem, and actions to be taken by the customer. The letter instructs the customer to stop using and to destroy the affected products. The firm recommends steps to follow when interpreting results. An acknowledgement and Product Replacement Form was enclosed for the customer to complete and return to the firm. Contact Biomerieux Customer Service representative at (800) 682-2666 for information regarding this notice.
Quantity in Commerce 100 kits
Distribution Distributed to one customer in California.
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.
510(K) Database 510(K)s with Product Code = JWX and Original Applicant = BIOMERIEUX VITEK, INC.
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