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Polymer Technology Systems, Inc.

Complete recall history across all FDA and CPSC categories — 14 total recalls

Polymer Technology Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by Polymer Technology Systems, Inc.

Date Product Reason Class
Jan 21, 2020 PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Pr... The firm is removing the product from the market after discussions with the F... Class II
Dec 2, 2019 Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with... One brand of batteries have a small dimensional difference in the negative bu... Class II
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, Refurbished analyzer, ... One brand of batteries have a small dimensional difference in the negative bu... Class II
Dec 2, 2019 Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036 One brand of batteries have a small dimensional difference in the negative bu... Class II
Dec 2, 2019 PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, w... One brand of batteries have a small dimensional difference in the negative bu... Class II
Jun 7, 2019 Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may d... Class III
Jun 7, 2019 PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may d... Class III
Jan 16, 2019 Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... Some lots of test strips do not fit tightly into the optical block, and may f... Class II
Jan 16, 2019 Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... Some lots of test strips do not fit tightly into the optical block, and may f... Class II
Jan 16, 2019 CHOL+HDL+GLU test strips, REF 2412 Some lots of test strips do not fit tightly into the optical block, and may f... Class II
Mar 14, 2018 PTS Panels¿ CHOL+GLU Test Strips (REF 1765) Potential for loss of activity of the glucose analyte (under-recovery) prior ... Class II
Mar 15, 2016 PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on Cardio... This lot of test strips is showing an under-recovery when tested against a re... Class II
Apr 4, 2013 PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Pr... Internal investigation demonstrated under-recovery for glucose when tested ag... Class II
May 15, 2012 PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are i... During a routine product investigation, a creatinine sample with a value less... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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