Indianapolis, IN, United States

Polymer Technology Systems, Inc. recalls

7 recalls recorded since 2018, most recently on 21 January 2020. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls7

Ongoing (FDA)0

Terminated or completed7

Class I (FDA)0

Recall started: 21 January 2020
Terminated: 14 December 2020
Reason: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Distribution: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Initiated: Voluntary: Firm initiated
Recall number: Z-1438-2020

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 (

Recall started: 2 December 2019
Terminated: 6 July 2020
Reason: 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 overheating.
Distribution: The products were distributed US Nationwide. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Bermuda, Canada, China, Chile, Costa Rica, Cayman Islands, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Jordan,
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0832-2020, Z-0834-2020, Z-0833-2020, Z-0835-2020

PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411

Recall started: 7 June 2019
Terminated: 8 July 2020
Reason: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Distribution: Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2157-2019, Z-2158-2019

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 triglyc
Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol,

Recall started: 16 January 2019
Terminated: 24 June 2020
Reason: 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
Distribution: Domestic distribution nationwide.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1373-2019, Z-1372-2019, Z-1371-2019

CHOL+HDL+GLU test strips, REF 2412
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

Recall started: 14 March 2018
Terminated: 13 September 2018
Reason: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
Distribution: OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Initiated: Voluntary: Firm initiated
Recall number: Z-1543-2018

Recall started: 2 December 2016
Terminated: 16 July 2020
Reason: 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.
Distribution: The products were distributed to the following US states: AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI TN, UT, VA, WA, and Puerto Rico. The products were distributed to the following foreign countries: Australia, Bahamas, Belgium, Bahrain, Bangladesh, Canada, China, Columbia, Czech Republi
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0683-2020, Z-0686-2020, Z-0682-2020, Z-0685-2020, Z-0684-2020

A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056

Recall started: 15 March 2016
Terminated: 5 June 2020
Reason: This lot of test strips is showing an under-recovery when tested against a reference method.
Distribution: The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
Initiated: Voluntary: Firm initiated
Recall number: Z-0741-2020

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.