Recall Z-0222-2007 ยท MJH Legionella, Spp., Elisa
Inverness Medical Professional Diagnostics
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000
| Date | Nov 29, 2006 (initiated Sep 29, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 Binax, Inc., Aug 21, 1998 |