Z-1506-2009

Inverness Medical BioStar Strep A OIA MAX, 100 test kit size

Name: Z-1506-2009 Inverness Medical BioStar Strep A OIA MAX, 100 test kit size
Creator: Binax, Inc. dba IMPD
Published: 2009-04-06
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2009-04-06 / Terminated

FDA source

Binax, Inc. dba IMPD began a recall of Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic on 2009-04-06. The reason FDA records is "Potential for false positive Strep A results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1506-2009
Status: Terminated
Initiated: 2009-04-06
Posted: 2009-06-24
Terminated: 2010-01-06
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
Product code: GTZ Antisera, All Groups, Streptococcus Spp.
Reason for recall: Potential for false positive Strep A results.
FDA root 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.
Product codes and lots: All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09; 196278, 196279, 196280, and 196281, expire 06/30/09.

Product code GTZ

K962060Class IStrep a Oia MaxBiostar, Inc. / cleared 1997-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)