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Terminated

Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.

FDA Recall Z-1506-2009 · Posted 2009-06-24

Recalling FirmBinax, Inc. dba IMPD
Recall StatusTerminated
Product CodeGTZ
Date Initiated2009-04-06
Date Terminated2010-01-06
Product Quantity1,729 kits

Reason for Recall

Potential for false positive Strep A results.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962060STREP A OIA MAXBiostar, Inc. · 1997-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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