Recall Z-2761-2019 ยท GFO Activated Partial Thromboplastin
Helena Laboratories, Corp.
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
| Date | Sep 27, 2019 (initiated Dec 7, 2017) |
| Status | Terminated |
| Reason | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. |
| Root cause | Unknown/Undetermined by firm |
| Action | The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot. |
| Quantity | 21 kits |
| Distribution | Distribution was made to Germany and Australia. There was no U.S. distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.