Polymer Technology Systems

Activity by year

Devices registered here (4)

• Enzymatic Esterase--Oxidase, Cholesterol
  Product code CHH (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1175
• Glucose Oxidase, Glucose
  Product code CGA (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
• System, Test, Blood Glucose, Over The Counter
  Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
• Ldl & Vldl Precipitation, Hdl
  Product code LBR (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1475

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…

FDA inspections (3)

• NAI2023-01-30
  No Action Indicated · Compliance: Devices
• VAI2021-09-07
  Voluntary Action Indicated · Compliance: Devices · citations posted
• OAI2019-02-15
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2019-07-31
  Warning Letter (opens in a new tab) · Whitestown Indiana

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by POLYMER TECHNOLOGY SYSTEMS, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)