The Recall Desk

Manufacturer

Polymer Technology Systems, Inc.

14 recalls in our database name Polymer Technology Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
0
Severe
1
Most recent
2020-03-11

Of the 14 recalls from Polymer Technology Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • ModerateFDA (Devices)·Z-1438-2020·2020-03-11

    Polymer Technology Systems Recalls PTS Detect Cotinine In Vitro Diagnostic

    Polymer Technology Systems is recalling PTS Detect Cotinine in vitro diagnostic devices due to a lack of FDA 510(k) clearance.

    Product
    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 professi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0835-2020·2020-01-29

    Polymer Technology Systems Recalls CardioChek Plus Analyzers Due to Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause reverse contact and potential overheating.

    Product
    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2020·2020-01-29

    PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause overheating if batteries are inserted incorrectly.

    Product
    PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2020·2020-01-29

    PTS Diagnostics CardioChek Plus Analyzer Recalled for Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 refurbished CardioChek Plus Professional Analyzers because a battery terminal defect may cause overheating if batteries are inserted incorrectly.

    Product
    PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2020·2020-01-01

    PTS Test Strips Recalled for Under-Recovery Against Reference Method

    Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.

    Product
    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
    Category
    Medical Device
    Distribution
    16 states
  • LowFDA (Devices)·Z-2158-2019·2019-08-14

    Polymer Technology Systems Recalls Mislabeled Lipid Panel Test Strips

    Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2157-2019·2019-08-14

    PTS Lipid Panel Test Strips Recalled for MEMo Chip Labeling Error

    Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.

    Product
    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 CardioCh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2019·2019-05-29

    Polymer Technology Systems Recalls CHOL+HDL+GLU Test Strips

    Polymer Technology Systems is recalling CHOL+HDL+GLU test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    CHOL+HDL+GLU test strips, REF 2412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips Due to Fit Issues

    Polymer Technology Systems is recalling Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect results.

    Product
    Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1372-2019·2019-05-29

    Polymer Technology Systems Recalls Lipid Panel Test Strips for Fit Issues

    Polymer Technology Systems is recalling certain Lipid Panel test strips because they may not fit tightly into the optical block, potentially causing incorrect test results.

    Product
    Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1543-2018·2018-05-09

    PTS CHOL+GLU Test Strips Recalled for Potential Loss of Glucose Activity

    Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips due to a potential loss of glucose analyte activity before the stated shelf life.

    Product
    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1403-2013·2013-06-05

    PTS Glucose Test Strips Recalled for Under-Recovery of Glucose

    Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2012·2012-07-04

    Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips

    Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.

    Product
    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 f
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

POLYMER TECHNOLOGY SYSTEMS, INC.

Source: Wikidata (Q140590878), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.