Molecular Erythrocyte Typing Test
FDA product code PEP · Class III (high risk) · Hematology
Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1109-2022 Class II | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the… | Luminex Corporation | 02/15/2022Open, Classified |