Recall Z-0374-04 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Beckman Coulter Inc
ICON 25 hCG test kit.
| Date | Jan 29, 2004 (initiated Dec 22, 2003) |
| Status | Terminated |
| Reason | Test can exhibit false negative results. |
| Root cause | Other |
| Action | Customer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.