Recall Z-0622-2019 ยท GKA Abnormal Hemoglobin Quantitation
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.
| Date | Nov 1, 2018 |
| Status | Terminated |
| Reason | lack of 510K |
| Root cause | No Marketing Application |
| Action | The firm initiated the recall by letter on 11/01/2018. The letter explained the problem and requested the return of the recalled items. |
| Quantity | 252 units |
| Distribution | IL, WV, NJ, AZ, MD, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.