BEUDAMED
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    PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·April 2, 2009

    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·February 20, 2009

    PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·June 5, 2009

    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·July 6, 2010

    PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CGA·August 4, 2009

    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·April 4, 2013

    PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code MRR·May 29, 2008

    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

    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

    FDA Recall
    Terminated ·Polymer Technology Systems·Product code LCP·December 2, 2016

    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

    FDA Recall
    Terminated ·Polymer Technology Systems·Product code LCP·December 2, 2016

    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

    FDA Recall
    Terminated ·Polymer Technology Systems·Product code LCP·December 2, 2016

    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

    FDA Recall
    Terminated ·Polymer Technology Systems·Product code LCP·December 2, 2016

    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

    FDA Recall
    Terminated ·Polymer Technology Systems·Product code LCP·December 2, 2016

    A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    ReliOn FastA1C Test, Software Version Revision D, REF Number 3055

    FDA Enforcement
    Class II ·Terminated·Polymer Technology Systems·December 25, 2019

    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·March 15, 2016

    PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·December 2, 2019