# FDA recall Z-2158-2019

> **Polymer Technology Systems, Inc.** · Class III · device recall initiated 2019-06-07.

## Product

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, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.

## Reason for recall

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

## Key facts

- **Recall number:** Z-2158-2019
- **Recalling firm:** Polymer Technology Systems, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-07
- **Report date:** 2019-08-14
- **Termination date:** 2020-07-08

- **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-2158-2019

## Citation

> AI Analytics. FDA recall Z-2158-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2158-2019. Source: US FDA. Licensed CC0.

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