Recall Z-0350-2023 ยท JPK Mixture, Hematology Quality Control
Primus Corporation dba Trinity Biotech
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, 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. Additionally, per the firm, 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 | 182 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 |