FDA Medical Device Recalls (openFDA)
Inverness Medical Professional Diagnostics: NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
- Recall number
- Z-0222-2007
- Recalling firm
- Inverness Medical Professional Diagnostics
- Product
- NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2006-11-29
- Terminated
- 2007-03-13
- Reason
- Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches
- Root cause
- Other
- Action
- Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level.
- Quantity
- 531 kits
- Distribution
- Worldwide, including USA, Canada, EU, South Korea, Singapore
- Lot, serial or model codes
- Lot Number: 024448 Exp. Date: March 14, 2008
- 510(k) numbers
- ["K982238"]
- PMA numbers
- not on file
- Product code
- MJH
- 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