Enzyme Immunoassay, Inhibin-a
Clinical Chemistry · 21 CFR 862.1260
Recent MDR events
27 adverse event reports on file
- DIMENSION VISTA®Dec 5, 2022MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2022-00302
- ACCESS INHIBIN A REAGENTApr 25, 2021MalfunctionBeckman Coulter2122870-2021-00049
- DIMENSION VISTA®Aug 15, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00459
- DIMENSION VISTA®Mar 28, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00196
- DIMENSION VISTA®Mar 26, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00193
- DIMENSION VISTA®Mar 26, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00192
- DIMENSION VISTA®Mar 26, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00191
- DIMENSION VISTA®Mar 26, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00194
- DIMENSION VISTA®Mar 26, 2018MalfunctionSiemens Healthcare Diagnostics Inc.2517506-2018-00195
- ACCESS INHIBIN ADec 27, 2017MalfunctionBeckman Coulter2122870-2017-00059
Event type breakdown
Recalls
3 recall events for this product code
- Beckman Coulter Inc.TerminatedSep 2, 2011
Inhibin A ELISA, Part Number: DSL-10-28100-4
The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761.
Z-3128-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedApr 8, 2011
Inhibin A ELISA kit, Part Number: DSL-10-28100-4
The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
Z-1925-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedApr 8, 2011
Inhibin A ELISA kit, Part Number: DSL-10-28100T-4
The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.
Z-1926-2011 · View FDA record ↗
Registered firms
9 firms currently registered for this product code
510(k) clearances
1 clearances for this product code