205 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CIN·November 10, 2011
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KLI·August 26, 2010
Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CIN·November 10, 2011
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
FDA Recall
Terminated
·Exactech, Inc.·Product code HTX·May 25, 2017
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code JIS·March 6, 2008
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
FDA Recall
Terminated
·Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila·Product code JIS·September 7, 2006
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
FDA Recall
Terminated
·Ortho Clinical Diagnostics Inc·Product code JIS·November 29, 2018
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JIS·July 27, 2011
ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JIS·March 13, 2013
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code JIS·March 13, 2013
Synchron Systems Lipid Calibrator (HDLD) Part 650218
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JIS·October 3, 2003
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIS·December 20, 2012
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
FDA Recall
Terminated
·Sentinel CH SpA Via Robert Koch·Product code JIS·July 29, 2021
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIS·February 23, 2017
Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JIS·May 10, 2011