Recall Z-2782-2016 ยท PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
| Date | Sep 12, 2016 (initiated Jul 11, 2016) |
| Status | Terminated |
| Reason | The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range). |
| Root cause | Nonconforming Material/Component |
| Action | Recall notification letters (dated 7/11/2016) were sent by FedEx on 7/11/2016. Customers were instructed to discontinue use of any remaining inventory (discard on site if any remaining). Customers were also advised that if the test resulted in a valid run, such that all Controls and Calibrator met the Quality Control Criteria as stated in the package insert, the patient results can be reported and a re-evaluation of patient results is not necessary. For questions, please contact Trinity Biotech's Help Desk at 1-800-325-3424 Option #3. |
| Quantity | US: 6 kits, Foreign: 50 kits |
| Distribution | Distribution to US nationwide including California, and China (Hong Kong). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140455 | CAPTIA MEASLES IGM Trinity Biotech USA, May 22, 2014 |