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    ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·December 18, 2019

    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·July 13, 2020

    Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista System. Creatinine measurements are used in the diagnosis and treatment of renal diseases in monitoring renal dialysis, and as a calculation basis for other urine analytes.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·February 12, 2010

    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·May 4, 2020

    VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·June 12, 2013

    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·May 4, 2020

    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code JFY·May 15, 2012

    Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc., Union City, CA Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum.

    FDA Recall
    Terminated ·Abaxis Inc·Product code JFY·November 16, 2009

    DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code JFY·February 12, 2009

    Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·July 15, 2015

    Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·December 18, 2019

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·July 11, 2018

    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·May 4, 2020

    Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista(R) System. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·June 10, 2010

    VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JFY·January 29, 2014

    Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JFY·May 7, 2015

    Dimension Vista Assays: Enzymatic Creatine (ECRE)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    ADVIA CHEMISTRY ENZYMATIC CREATININE_2

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    Dimension Assays: ENZYMATIC CREATININE

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JFY·March 17, 2016

    Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JFY·August 15, 2019