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U.S. Department of Health and Human Services

Class 2 Device Recall Inverness Medical BioStar Strep A OIA MAX

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  Class 2 Device Recall Inverness Medical BioStar Strep A OIA MAX see related information
Date Initiated by Firm April 06, 2009
Date Posted June 24, 2009
Recall Status1 Terminated 3 on January 06, 2010
Recall Number Z-1506-2009
Recall Event ID 51871
510(K)Number K962060  
Product Classification strep test in vitro diagnostic - Product Code GTZ
Product Inverness Medical BioStar Strep A OIA MAX, 100 test kit size,
Product Code: 90003, in vitro diagnostic.
Code Information All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09;  196278, 196279, 196280, and 196281, expire 06/30/09.  
Recalling Firm/
Binax, Inc. dba IMPD
10 Southgate Rd
Scarborough ME 04074
For Additional Information Contact Same as Above
Manufacturer Reason
for Recall
Potential for false positive Strep A results.
FDA Determined
Cause 2
Action Inverness Medical notified Customers by letter sent via Fedex April 6, 2009 . The letter included a request for a response from the customer. The product is discontinued.
Quantity in Commerce 1,729 kits
Distribution Nationwide.
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 = GTZ and Original Applicant = BIOSTAR, INC.