# FDA recall Z-1543-2018

> **Polymer Technology Systems, Inc.** · Class II · device recall initiated 2018-03-14.

## Product

PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

## Reason for recall

Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

## Distribution

OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England

## Key facts

- **Recall number:** Z-1543-2018
- **Recalling firm:** Polymer Technology Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-14
- **Report date:** 2018-05-09
- **Termination date:** 2018-09-13

- **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-1543-2018

## Citation

> AI Analytics. FDA recall Z-1543-2018. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1543-2018. Source: US FDA. Licensed CC0.

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