Recall Z-0349-2023 ยท JPK Mixture, Hematology Quality Control
Primus Corporation dba Trinity Biotech
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
| Date | Dec 1, 2022 (initiated Oct 5, 2021) |
| Status | Terminated |
| Reason | The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent an Urgent Filed Safety Notice their consignees on 10/05/2021 by mail. The notice explained the issue, risk and requested the destruction of of the affected devices. |
| Quantity | 340 kits |
| Distribution | Turkey, India, Romania, Thailand, Vietnam, S. Korea, Peru, Pakistan Austria, UAE, Chile, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952720 | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II Aalto Scientific, Ltd., Sep 20, 1995 |