FDA Medical Device Recalls (openFDA)
Binax, Inc. dba IMPD: BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
- Recall number
- Z-0822-2007
- Recalling firm
- Binax, Inc. dba IMPD
- Product
- BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
- Status
- Terminated
- Initiated
- 2007-03-28
- Posted
- 2007-05-23
- Terminated
- 2008-09-08
- Reason
- Tip of the foam swab could detach from the shaft causing injury to the patient.
- Root cause
- Other
- Action
- Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical.
- Quantity
- 2688 kits
- Distribution
- Nationwide and Japan.
- Lot, serial or model codes
- Kit Lot Numbers: 023378, 023411, 023433, 023616, 024021, 024384, 024479, 024480, 024622 NP Swabs Lot Number: 8995
- 510(k) numbers
- ["K062109"]
- PMA numbers
- not on file
- Product code
- GNX
- 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