# FDA recall Z-1255-2019

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2019-04-03.

## Product

G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618    Product Usage:  This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

## Reason for recall

The target values and ranges in these lots are incorrect.

## Distribution

The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

## Key facts

- **Recall number:** Z-1255-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-03
- **Report date:** 2019-05-08
- **Termination date:** 2019-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2019

## Citation

> AI Analytics. FDA recall Z-1255-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1255-2019. Source: US FDA. Licensed CC0.

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