RegWardenFDA facility compliance records
Company

POLYMER TECHNOLOGY SYSTEMS, INC.

11 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2016: 2 recalls; 2018: 1 recalls; 2019: 3 recalls; 2020: 1 recalls; 2022: 1 recalls; 2024: 1 recalls1’121’13’14’152’16’171’183’191’20’211’22’231’24’25’26
  • Recalls (11)

Registered facilities (1)

Recalls & enforcement

  • Class IICompleted2024-09-18
    The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot num…
  • Class IIICompleted2022-08-16
    Incorrect instructions for use were packaged into the final product.
  • Class IITerminated2020-01-21
    The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
  • Class IITerminated2019-12-02
    One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheatin…
  • Class IIITerminated2019-06-07
    The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
  • Class IITerminated2019-01-16
    Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
  • Class IITerminated2018-03-14
    Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
  • Class IITerminated2016-12-02
    A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
  • Class IITerminated2016-03-15
    This lot of test strips is showing an under-recovery when tested against a reference method.
  • Class IITerminated2013-04-04
    Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
  • Class IITerminated2012-05-15
    During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine as…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “POLYMER TECHNOLOGY SYSTEMS, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9031081-polymer-technology-systems-inc/

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