Test, Hiv Detection
Microbiology · 21 CFR 866.3956
Recent MDR events
3,187 adverse event reports on file
- Elecsys HIV combi PTJul 31, 2026MalfunctionRoche Diagnostics1823260-2026-03129
- cobas® HIV-1 (192T)Jul 31, 2026MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2026-03131
- Elecsys HIV DuoJul 29, 2026MalfunctionRoche Diagnostics1823260-2026-03059
- Elecsys HIV DuoJul 29, 2026MalfunctionRoche Diagnostics1823260-2026-03060
- ARCHITECT HIV Ag/Ab ComboJul 29, 2026MalfunctionAbbott Gmbh3002809144-2026-00206
- Alinity i HIV Ag/Ab Combo Reagent KitJul 29, 2026MalfunctionAbbott Gmbh3002809144-2026-00209
- Elecsys HIV DuoJul 28, 2026MalfunctionRoche Diagnostics1823260-2026-03010
- Elecsys HIV DuoJul 28, 2026MalfunctionRoche Diagnostics1823260-2026-03011
- Elecsys HIV DuoJul 28, 2026MalfunctionRoche Diagnostics1823260-2026-03032
- Elecsys HIV DuoJul 28, 2026MalfunctionRoche Diagnostics1823260-2026-03036
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
64 firms currently registered for this product code
Abbott Molecular, Inc.
Des Plaines, IL, US
F.m. Howell & Co.
ELMIRA, NY, US
Bio-rad Laboratories, Inc.
Hercules, CA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Hologic, Inc.
SAN DIEGO, CA, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Diasorin Italia S.p.a.
SALUGGIA Vercelli, IT
Chembio Diagnostic Systems, Inc.
MEDFORD, NY, US
Abbott Molecular Distribution Center
Itasca, IL, US
Chembio Diagnostic Systems
Bay Shore, NY, US
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Tosoh Corp.
Chuo-ku Tokyo, JP
Diasorin Italia S.p.a Uk Branch
Dartford Kent, GB
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Ortho-clinical Diagnostics
Pencoed Bridgend, GB
Tosoh Bioscience, Inc.
Grove City, OH, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.