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Polymer Technology Systems Recalls
19 recalls on record · July 4, 2012 to March 11, 2020 · Medical Devices
Recalls by year
12
13
18
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
March 11, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system
Hazard: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
January 29, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 5
Hazard: 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.
January 29, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Hazard: 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.
January 29, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Num
Hazard: 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.
January 29, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Hazard: 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.
January 1, 2020Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Hazard: This lot of test strips is showing an under-recovery when tested against a reference method.
December 25, 2019Medical DevicesFDA
Polymer Technology Systems recalls CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Hazard: 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.
December 25, 2019Medical DevicesFDA
Polymer Technology Systems recalls ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
Hazard: 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.
December 25, 2019Medical DevicesFDA
Polymer Technology Systems recalls Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
Hazard: 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.
December 25, 2019Medical DevicesFDA
Polymer Technology Systems recalls A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
Hazard: 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.
December 25, 2019Medical DevicesFDA
Polymer Technology Systems recalls A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038,
Hazard: 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.
August 14, 2019Medical DevicesFDA
Polymer Technology Systems, Inc. recalls Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS P
Hazard: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
August 14, 2019Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid
Hazard: The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
May 29, 2019Medical DevicesFDA
Polymer Technology Systems, Inc. recalls CHOL+HDL+GLU test strips, REF 2412
Hazard: 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
May 29, 2019Medical DevicesFDA
Polymer Technology Systems, Inc. recalls Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-
Hazard: 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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
May 29, 2019Medical DevicesFDA
Polymer Technology Systems, Inc. recalls Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
Hazard: 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.
May 9, 2018Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Hazard: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
June 5, 2013Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare profession
Hazard: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
July 4, 2012Medical DevicesFDA
Polymer Technology Systems, Inc. recalls PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole bloo
Hazard: 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 assay.