JPBClass II
Hemoglobin M
Hematology · 21 CFR 864.7415
MDR events0All time
Recalls2All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Helena Laboratories, Inc.TerminatedUnknown
Cascade Abrazo c-ACT-LR Test Card
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Z-0561-2019 · View FDA record ↗ - Helena Laboratories, Inc.TerminatedUnknown
Cascade Abrazo c-ACT-LR Test Card
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Z-0594-2019 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.