FDA Medical Device Recalls (openFDA)
Inverness Medical BioStar Inc.: BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
- Recall number
- Z-0212-2009
- Recalling firm
- Inverness Medical BioStar Inc.
- Product
- BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027
- Status
- Terminated
- Initiated
- 2008-07-02
- Posted
- 2008-11-03
- Terminated
- 2008-11-04
- Reason
- Diagnostic kits for flu were distributed with incorrect components.
- 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
- 509 kits
- Distribution
- Nationwide Distribution --- including state of IL.
- Lot, serial or model codes
- Lot # 193130DA Lot trace: 193198, 193198-2, 193199, 193199-2, 194062, 194062-2.
- 510(k) numbers
- ["K023556"]
- PMA numbers
- not on file
- Product code
- GNX
- Firm FEI
- 1720655
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28