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 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

    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

    PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700

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

    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019

    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

    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

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

    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·January 16, 2019

    CHOL+HDL+GLU test strips, REF 2412

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CGA·January 16, 2019

    Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036

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

    PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·June 7, 2019

    PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code MRS·January 21, 2020

    Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code CHH·June 7, 2019

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Recall
    Terminated ·Polymer Technology Systems, Inc.·Product code NBW·March 14, 2018