NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
FDA device recall Z-0222-2007 · posted 2006-11-29 · Terminated
Recall details
- Recalling firm
- Inverness Medical Professional Diagnostics
- Reason for recall
- Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MJH
- Quantity affected
- 531 kits
- Distribution
- Worldwide, including USA, Canada, EU, South Korea, Singapore
- Date initiated
- 2006-09-29
- Date posted
- 2006-11-29
- Date terminated
- 2007-03-13
- Location
- Scarborough, ME
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238) | Binax, Inc. | 1998-08-21 |