Recall Z-0136-06 ยท GGT Assay, Erythropoietin
Nichols Institute Diagnostics
Nichols Advantage EPO Calibration Verifiers, Catalog #63-7512
| Date | Nov 15, 2005 (initiated Sep 30, 2005) |
| Status | Terminated |
| Reason | Some units in Lot 30-500953 (Calibration Verifier 2) are mislabeled as Calibration Verifier 3. Some units of Lot 30-500953 (Calibration Verifier 3) are mislabeled as Calibration Verifier 2. |
| Root cause | Other |
| Action | Written notification was sent via fax on 9/29/05. If receipt was not confirmed, written version of notification was mailed via next day delivery. NID intends to track the response forms and if after 2 weeks after distribution not all forms have been received, NID will conduct a follow-up phone call and resend if necessary. |
| Quantity | 215 |
| Distribution | CA, IN, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.