Polymer Technology Systems, Inc.: FDA recalls

FDA enforcement events from 2012 to 2020; export dated 3 Nov 2026. The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Polymer Technology Systems, Inc. as the recalling firm in 8 events. The events have 14 product records. The recalls started from 2012 to 2020. All the events are device recalls. By FDA enforcement events, Polymer Technology Systems, Inc. is number 442 of 1,628 firms that have a page. Events that Polymer Technology Systems, Inc. started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 87.5% of its events and 73.7% of all FDA events.

See the 8 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Enforcement events

8 events, newest first.

FDA enforcement events of Polymer Technology Systems, Inc.
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

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Polymer Technology Systems, Inc.: events for each product type
Type		Events
Device		8

Polymer Technology Systems, Inc.: events in each class
Class		Events
Class II		7
Class III		1

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Polymer Technology Systems, Inc., by the year that the recall started. The largest year is 2019, with 3 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Polymer Technology Systems, Inc.: FDA recalls. https://recallregister.com/firm/polymer-technology-systems-inc/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
State of the firm address: IN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Polymer Technology Systems, Inc. have?: Class II: 7 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Polymer Technology Systems, Inc.?: FDA event 84840, which the firm started on 21 Jan 2020. The first product in the record is: 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…
How many FDA recalls of Polymer Technology Systems, Inc. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.