FDA Medical Device Recalls (openFDA)
Binax, Inc. dba IMPD: Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
- Recall number
- Z-1506-2009
- Recalling firm
- Binax, Inc. dba IMPD
- Product
- Inverness Medical BioStar Strep A OIA MAX, 100 test kit size, Product Code: 90003, in vitro diagnostic.
- Status
- Terminated
- Initiated
- 2009-04-06
- Posted
- 2009-06-24
- Terminated
- 2010-01-06
- Reason
- Potential for false positive Strep A results.
- 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
- 1,729 kits
- Distribution
- Nationwide.
- Lot, serial or model codes
- All lots: 196070, 196071, 196073, 196074, and 198052 expire 05/31/09; 196278, 196279, 196280, and 196281, expire 06/30/09.
- 510(k) numbers
- ["K962060"]
- PMA numbers
- not on file
- Product code
- GTZ
- Firm FEI
- 1221359
- Firm city
- Scarborough
- Firm state
- ME
- 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