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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = JWX
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