Recall Z-0324-05 ยท CFP Radioimmunoassay, Immunoreactive Insulin
Diagnostic Products Corp
Immulite 2500 insulin Kit
| Date | Dec 17, 2004 (initiated Nov 19, 2004) |
| Status | Terminated |
| Reason | Low bias of 10 to 40% at different levels of insulin in samples. |
| Root cause | Other |
| Action | Customers were notified by telephone on 11/19/2004. They were instructed to discard remaining kits. |
| Quantity | 10 kits |
| Distribution | Medical facilities in AK, NY, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.