Z-0212-2009

BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

Name: Z-0212-2009 BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Creator: Inverness Medical BioStar Inc.
Published: 2008-07-02
License: https://open.fda.gov/license/

Inverness Medical-Biostar, Inc. / initiated 2008-07-02 / Terminated

FDA source

Inverness Medical BioStar Inc. began a recall of BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027 on 2008-07-02. The reason FDA records is "Diagnostic kits for flu were distributed with incorrect components". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0212-2009
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-11-03
Terminated: 2008-11-04
Recalling firm: Inverness Medical-Biostar, Inc.
Product: BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
Product code: GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Reason for recall: Diagnostic kits for flu were distributed with incorrect components.
FDA root cause: 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.
Product codes and lots: Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.

Product code GNX

K023556Class IIFlu Oia A/b Test KitThermo Biostar, Inc. / cleared 2003-03-27

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)