Polymer Technology Systems, Inc.

FDA recalling firm · 8 enforcement events · 14 product records · 2012–2020 · IN

Polymer Technology Systems, Inc. has 8 FDA enforcement events on this register (14 product records) between 2012 and 2020: 8 device; the busiest year was 2019 with 3.

0% of its events are Class I; the most common class is Class II (7). 0 events are listed as ongoing; the recalling firm's address is in IN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
21 Jan 2020	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…	Device	Class II	1	Terminated
2 Dec 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700	Device	Class II	4	Terminated
7 Jun 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…	Device	Class III	2	Terminated
16 Jan 2019	Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414	Device	Class II	3	Terminated
14 Mar 2018	PTS Panels¿ CHOL+GLU Test Strips (REF 1765)	Device	Class II	1	Terminated
15 Mar 2016	PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers	Device	Class II	1	Terminated
4 Apr 2013	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	Device	Class II	1	Terminated
15 May 2012	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…	Device	Class II	1	Terminated

By type and class

Device8

Class II7

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Polymer Technology Systems, Inc. by year initiated.

Questions and answers

How many FDA recalls has Polymer Technology Systems, Inc. had?

8 enforcement events (14 product records) on this register, 2012–2020: 8 device.

Are any Polymer Technology Systems, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Polymer Technology Systems, Inc. recalls?

7 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.