Kit, Test, Alpha-fetoprotein For Neural Tube Defects
Unknown
Recent MDR events
159 adverse event reports on file
- Alinity i AFP Reagent KitJul 27, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00106
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00126
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00127
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00128
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00129
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00131
- IMMULITE 2000 AFPJun 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00130
- ATELLICA IM ALPHA FETOPROTEIN (AFP)Jun 15, 2026MalfunctionSiemens Healthcare Diagnostics, Inc.1219913-2026-00113
- ALINITY I AFP REAGENT KITApr 20, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00066
- ATELLICA IM ALPHA FETOPROTEIN (AFP)Feb 24, 2026MalfunctionSiemens Healthcare Diagnostics, Inc.1219913-2026-00048
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
11 firms currently registered for this product code
Wallac Oy
TURKU Varsinais-Suomi, FI
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Abbott Gmbh
Wiesbaden Hesse, DE
Abbott Laboratories
Lake Forest, IL, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Beckman Coulter, Inc.
CHASKA, MN, US
Acro Biotech Inc.
Montclair, CA, US
Abbott Ireland
SLIGO, IE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
11 premarket approvals for this product code
- Abbott LaboratoriesNov 28, 2012
P120008 · ABBOTT ARCHITECT AFP ASSAY
- Siemens Healthcare Diagnostics, Inc.Nov 9, 2001
P010007 · IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
- Beckman Coulter, Inc.Feb 8, 1999
P980041 · ACCESS AFP IMMUNOASSAY SYSTEM
- Revvity, Inc.Mar 31, 1998
P970037 · AUTODELFIA HAFP TEST KIT
- Siemens Healthcare Diagnostics, Inc.Sep 29, 1995
P930036 · ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
- Incstar Corp.Apr 30, 1986
P790032 · GAMMA DAB (125I) AFP RIA KIT
- Abbott LaboratoriesJun 25, 1984
P780005 · ABBOTT AFP
- Ortho Clinical DiagnosticsJun 7, 1984
P780006 · AMERSHAM AFP