Hemoglobin M
FDA product code JPB · Class II (moderate risk) · 21 CFR 864.7415 · Hematology
0510(k) clearances
0PMA approvals
2recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0561-2019 Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C…Due to some cards in this lot reported to have experienced variations in results, (verified by wave form)… | Helena Laboratories, Inc. | 02/24/2017Terminated |
| Z-0594-2019 Class II | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C…Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or… | Helena Laboratories, Inc. | 04/20/2016Terminated |