Recall Z-0163-04 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Beckman Coulter Inc
ICON 25 hCG Test Kit
| Date | Jul 20, 2004 (initiated Oct 31, 2003) |
| Status | Terminated |
| Reason | False negative urine results are being observed at an increasing rate. |
| Root cause | Other |
| Action | Firm sent letter to customers on 31 OCT 03 expressing not to use kits and that another lot will be substituted. Destruction of recalled lot is requested. |
| Quantity | 9040 kits |
| Distribution | Nationwide and Canada (limited). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.