Albumin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5040
Recent MDR events
65 adverse event reports on file
- Tina-quant Albumin Gen.2 - Urine ApplicationJul 27, 2026MalfunctionRoche Diagnostics1823260-2026-02990
- TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATIONJun 8, 2026MalfunctionRoche Diagnostics1823260-2026-02250
- TINA-QUANT ALBUMIN GEN.2May 27, 2026MalfunctionRoche Diagnostics1823260-2026-02080
- TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATIONMar 19, 2026MalfunctionRoche Diagnostics1823260-2026-01003
- ATELLICA CH URINE ALBUMIN (UALB)Feb 19, 2026MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2026-00058
- ATELLICA CH URINE ALBUMIN (UALB)Feb 18, 2026MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2026-00054
- N ANTISERUM TO HUMAN ALBUMINFeb 16, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00003
- N ANTISERUM TO HUMAN ALBUMINFeb 16, 2026MalfunctionSiemens Healthcare Diagnostics Products Gmbh9610806-2026-00004
- TINA-QUANT ALBUMIN GEN.2Feb 16, 2026MalfunctionRoche Diagnostics1823260-2026-00527
- ATELLICA CH URINE ALBUMIN (UALB)Feb 12, 2026MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2026-00044
Event type breakdown
Recalls
3 recall events for this product code
- Wako Life Sciences, Inc.TerminatedJul 30, 2013
uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Dia
Product fails to meet the accuracy at the low end of the measuring range.
Z-1831-2013 · View FDA record ↗ - Ortho Clinical Diagnostics IncTerminatedUnknown
7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using th
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days
Z-0739-2020 · View FDA record ↗ - Beckman Coulter Inc.TerminatedUnknown
Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL
Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
Z-2124-2017 · View FDA record ↗
Registered firms
65 firms currently registered for this product code
Beckman Coulter, Inc.
BREA, CA, US
Stanbio Laboratory
Boerne, TX, US
Tst Biomedical Electronics Co., Ltd.
Taoyuan, TW
The Binding Site
Kings Norton Birmingham, GB
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Nittobo Medical Co., Ltd. Medical Development Center
Koriyama Fukushima, JP
Sanzay Corporation -
Miami Gardens, FL, US
Sekisui Diagnostics P.e.i. Inc.
CHARLOTTETOWN Prince Edward Island, CA
Horiba Abx Sas
MONTPELLIER Herault, FR
Ortho Clinical Diagnostics
Singapore South West, SG
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Carolina Liquid Chemistries
Brea, CA, US
Immundiagnostik Ag
Bensheim Hesse, DE
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Kamiya Biomedical Company Llc
Tukwila, WA, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Acro Biotech Inc.
Montclair, CA, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
510(k) clearances
37 clearances for this product code
- The Binding Site Group , Ltd.Aug 25, 2016
K153560 · Optilite Low Level Albumin Kit
- The Binding Site Group , Ltd.May 26, 2015
K143118 · Human Microalbumin kit for use on SPAPLUS
- Beckman Coulter Ireland, Inc.Oct 15, 2014
K142346 · Urine/CSF Albumin, Urine/CSF Albumin Calibrator
- The Binding Site Group , Ltd.Jun 19, 2013
K121045 · HUMAN ALBUMIN CSF KIT
- Roche Diagnostics OperationsMay 14, 2012
K113072 · TINA-QUANT ALBUMIN GEN.2
- Medica Corp.Jul 13, 2011
K101089 · EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR
- Roche DiagnosticsSep 10, 2010
K101203 · TINA-QUANT ALBUMIN GEN 2
- Roche Diagnostics Corp.Sep 9, 2010
K100853 · COBAS 8000 MODULAR SERIES ANALYZER