QHMUnclassified
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
Microbiology · 21 CFR 610.40
For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
MDR events527All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
527 adverse event reports on file
- Alinity s HTLV I/II Reagent KitJul 22, 2026MalfunctionAbbott Gmbh3002809144-2026-00197
- ALINITY S CHAGAS REAGENT KITJun 23, 2026MalfunctionAbbott Laboratories1415939-2026-00016
- ALINITY S CHAGAS REAGENT KITJun 23, 2026MalfunctionAbbott Laboratories1415939-2026-00015
- ALINITY S ANTI-HBC REAGENT KITJun 15, 2026MalfunctionAbbott Laboratories1415939-2026-00014
- ELECSYS ANTI-HBC IIJun 3, 2026MalfunctionRoche Diagnostics1823260-2026-02193
- ELECSYS HTLV-I/IIMay 29, 2026MalfunctionRoche Diagnostics1823260-2026-02126
- ELECSYS HIV DUOMay 19, 2026MalfunctionRoche Diagnostics1823260-2026-01977
- ELECSYS HTLV-I/IIMay 14, 2026MalfunctionRoche Diagnostics1823260-2026-01900
- ALINITY S HTLV I/II REAGENT KITApr 28, 2026MalfunctionAbbott Laboratories1415939-2026-00012
- ALINITY S HIV AG/AB COMBO REAGENT KITApr 27, 2026MalfunctionAbbott Gmbh3002809144-2026-00105
Event type breakdown
Malfunction402
Injury125
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.