Device recall: Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

Class II FDA enforcement event 82331. Recall start date: 16 Jan 2019. Status in the FDA record: Terminated. Termination date: 24 Jun 2020.

Reason for recall, in the words of FDA

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 II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Polymer Technology Systems, Inc. started this device recall on 16 Jan 2019. The firm address in the FDA record is in Indianapolis, IN. FDA put the recall in Class II. FDA event 82331 has 3 product records. The first FDA enforcement report date is 29 May 2019. The record gives the status Terminated, with the termination date 24 Jun 2020.

FDA enforcement report The 3 product records

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 28 Sep 2026.

Distribution

In the words of FDA.

Domestic distribution nationwide.

Recalling firm

Polymer Technology Systems, Inc., Indianapolis, IN.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

3 product records in the event.

FDA event 82331: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1371-2019	Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414	67643 total	Class II	Terminated	29 May 2019
Z-1372-2019	Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412	67643 total	Class II	Terminated	29 May 2019
Z-1373-2019	CHOL+HDL+GLU test strips, REF 2412	67643 total	Class II	Terminated	29 May 2019

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Polymer Technology Systems, Inc.
Initiated	Product (first record)	Type	Class	Records
21 Jan 2020	PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system	Device	Class II	1
2 Dec 2019	PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700	Device	Class II	4
7 Jun 2019	PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel te	Device	Class III	2
14 Mar 2018	PTS Panels CHOL+GLU Test Strips (REF 1765)	Device	Class II	1
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
4 Apr 2013	PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals	Device	Class II	1
15 May 2012	PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood.	Device	Class II	1

Polymer Technology Systems, Inc.: all 8 events

Official channels

FDA enforcement report Z-1371-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82331. https://recallregister.com/fda/ii/82331/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Domestic distribution nationwide.
What quantity of product is in FDA event 82331?: The event has 3 product records. The first record gives this quantity: 67643 total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.