# FDA recall Z-0741-2020

> **Polymer Technology Systems, Inc.** · Class II · device recall initiated 2016-03-15.

## Product

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

## Reason for recall

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.

## Key facts

- **Recall number:** Z-0741-2020
- **Recalling firm:** Polymer Technology Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-03-15
- **Report date:** 2020-01-01
- **Termination date:** 2020-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0741-2020

## Citation

> AI Analytics. FDA recall Z-0741-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0741-2020. Source: US FDA. Licensed CC0.

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