FDA Medical Device Recalls (openFDA)
Binax, Inc.: NOW RSV Test Item Number 430-430, Kit Number 430-00R
- Recall number
- Z-0778-04
- Recalling firm
- Binax, Inc.
- Product
- NOW RSV Test Item Number 430-430, Kit Number 430-00R
- Status
- Terminated
- Initiated
- 2004-02-18
- Posted
- 2004-07-20
- Terminated
- 2004-08-09
- Reason
- Pouch integrity compromised
- Root cause
- Other
- Action
- Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
- Quantity
- 667 kits
- Distribution
- KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
- Lot, serial or model codes
- Lot # 015168 and 015172
- 510(k) numbers
- ["K032166"]
- PMA numbers
- not on file
- Product code
- GQG
- Firm FEI
- 1221359
- Firm city
- Portland
- 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