Calibrator For Hemoglobin And Hematocrit Measurement
Hematology · 21 CFR 864.8165
Recent MDR events
21 adverse event reports on file
- C.F.A.S. HBA1CNov 23, 2022MalfunctionRoche Diagnostics1823260-2022-03763
- C.F.A.S. HBA1CSep 17, 2018MalfunctionRoche Diagnostics1823260-2018-03161
- C.F.A.S. HBA1CSep 17, 2018MalfunctionRoche Diagnostics1823260-2018-03160
- CELL-DYN 22 CALIBRATORSep 6, 2007MalfunctionAbbott Laboratories2919069-2007-00136
- CELL-DYN 22 CALIBRATORAug 17, 2007MalfunctionAbbott Diagnostics Division/celldyn2919069-2007-00125
- CELL-DYN 22 CALIBRATORDec 4, 2006MalfunctionAbbott Diagnostics Division/celldyn2919069-2006-00118
- CELL-DYN 22 CALIBRATORDec 1, 2006MalfunctionAbbott Diagnostics Div/celldyn2919069-2006-00106
- CELL-DYN 22 CALIBRATORDec 1, 2006MalfunctionAbbott Laboratories Division/celldyn2919069-2006-00111
- CELL-DYN 22 CALIBRATORDec 1, 2006MalfunctionAbbott Diagnostics Div/celldyn2919069-2006-00107
- CELL-DYN 22 CALIBRATORDec 1, 2006MalfunctionAbbott Diagnostics Div/celldyn2919069-2006-00108
Event type breakdown
Recalls
2 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.Open, ClassifiedJul 3, 2025
ADVIA 120/2120/2120i SETpoint Calibrator
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Z-2086-2025 · View FDA record ↗ - Bio-Rad Laboratories, Inc.TerminatedJan 11, 2012
VARIANT II Link Hemoglobin A1c Program Reorder Pack,
It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
Z-0399-2012 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Clinical Diagnostic Solutions, Inc.
PLANTATION, FL, US
Dirui Industrial Co., Ltd.
CHANGCHUN Jilin, CN
Bio-rad Laboratories, Inc.
Hercules, CA, US
Abbott Laboratories
Lake Forest, IL, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Streck Llc
La Vista, NE, US
R & D Systems, Inc.
MINNEAPOLIS, MN, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Sts Corporation
Duluth, GA, US
Horiba Abx Sas
MONTPELLIER Herault, FR
Jas Diagnostics/drew Scientific
Plantation, FL, US
Abbott Laboratories
Irving, TX, US
Nova Biomedical Corporation
Billerica, MA, US
Nova Biomedical Corporation
WALTHAM, MA, US
Beckman Coulter, Inc.
BREA, CA, US
Shenzhen Mindray Bio-medical Electronics Co.,ltd
SHENZHEN Guangdong, CN
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
25 clearances for this product code
- Roche DiagnosticsAug 26, 2005
K052101 · C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
- Clinical Diagnostic Solutions, Inc.Jun 10, 2004
K041130 · CDS HEMATOLOGY CALIBRATOR (CDS CAL)
- Alko Diagnostic Corp.Dec 18, 1996
K962864 · THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
- Alko Diagnostic Corp.Jul 24, 1995
K951071 · ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
- Unipath , Ltd.Sep 10, 1990
K902892 · CELL-DYN CALIBRATOR
- Reagents Applications, Inc.Jan 25, 1990
K896921 · RAICHEM TM HEMOGLOBIN CALIBRATOR
- R&D Systems, Inc.Aug 15, 1989
K893984 · HGB-CAL SET/MULTIPLE
- Medical Specialties, Inc.Nov 22, 1988
K883850 · MSI-CAL 16