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U.S. Department of Health and Human Services

Class 2 Device Recall In vitro diagnostic for influenza A and B.

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  Class 2 Device Recall In vitro diagnostic for influenza A and B. see related information
Date Initiated by Firm July 02, 2008
Date Posted November 03, 2008
Recall Status1 Terminated 3 on November 04, 2008
Recall Number Z-0212-2009
Recall Event ID 49385
510(K)Number K023556  
Product Classification Cf Influenza Virus A, B, C Antigens - Product Code GNX
Product BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Code Information Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.
Recalling Firm/
Manufacturer		 Inverness Medical BioStar Inc.
331 S 104th St
Louisville CO 80027-9713
For Additional Information Contact
207-730-5740
Manufacturer Reason
for Recall		 Diagnostic kits for flu were distributed with incorrect components.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.
Quantity in Commerce 509 kits
Distribution Nationwide Distribution --- including state of IL.
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 = GNX and Original Applicant = THERMO BIOSTAR, INC.
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