Polymer Technology Systems recalls
Polymer Technology Systems appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2024-10-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 21 |
|---|---|
| Published | 2012-07-04 to 2024-10-30 |
| By agency | FDA Device (21) |
| By classification | Class II (18), Class III (3) |
| By status | terminated (19), completed (2) |
| Distribution named in notices | AR, CA, CT, FL, IL, IN, KY, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, PA, PR, RI, TN, US, UT, VA, WA, WI |
Recalls
- A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing d…
FDA Device · Class II · 2024-10-30 · Polymer Technology Systems
Reason: The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result… - PTS Panels CHOL+GLU Test Strips (REF 1765)
FDA Device · Class III · 2022-09-21 · Polymer Technology Systems
Reason: Incorrect instructions for use were packaged into the final product. - PTS Detect Cotinine, Ref
FDA Device · Class II · 2020-03-11 · Polymer Technology Systems
Reason: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. - PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, without box or carrying case, Reference Numbers 2702
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems
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 contac… - PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems
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 contac… - Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems
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 contac… - Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
FDA Device · Class II · 2020-01-29 · Polymer Technology Systems
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 contac… - PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
FDA Device · Class II · 2020-01-01 · Polymer Technology Systems
Reason: This lot of test strips is showing an under-recovery when tested against a reference method. - Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems
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. - A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems
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. - A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems
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. - ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems
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. - CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems
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. - Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test str…
FDA Device · Class III · 2019-08-14 · Polymer Technology Systems
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 - PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure t…
FDA Device · Class III · 2019-08-14 · Polymer Technology Systems
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 - Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems
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 di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a comp… - Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems
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. - CHOL+HDL+GLU test strips, REF 2412
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems
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 - PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
FDA Device · Class II · 2018-05-09 · Polymer Technology Systems
Reason: Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) - PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals wit…
FDA Device · Class II · 2013-06-05 · Polymer Technology Systems
Reason: Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. - PTS Panels Creatinine test strips
FDA Device · Class II · 2012-07-04 · Polymer Technology Systems
Reason: 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 meas…