Recall Z-0706-03 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Beckman Coulter Inc
ICON DS hCG, an in-vitro diagnostic. Part number 44025.
| Date | Apr 2, 2003 (initiated Feb 20, 2003) |
| Status | Terminated |
| Reason | Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports. |
| Root cause | Other |
| Action | Distributors/customers were sent a recall letter dated 2/20/03 instructing them to discontinue use of the product. |
| Quantity | 12,804 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993203 | ACON ONE STEP PREGNANCY TEST STRIP (URINE) ACON Laboratories, Inc., Dec 1, 1999 |