Class 2 Device Recall Inverness Medical BioStar Strep A OIA MAX

• Date Initiated by Firm: April 06, 2009
• Date Posted: June 24, 2009
• Recall Status: Terminated 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/ Manufacturer: Binax, Inc. dba IMPD; 10 Southgate Rd; Scarborough ME 04074
• For Additional Information Contact: Same as Above; 207-730-7740
• Manufacturer Reason for Recall: Potential for false positive Strep A results.
• FDA Determined Cause: Other
• 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