# FDA recall Z-1057-2019

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2019-02-13.

## Product

Randox Blood Gas Control Level 2 -Model BG5002.  In-vitro Diagnostic Quality control of Blood Gas analysis    This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

## Reason for recall

An error in the assignment of the control range pH in Blood Gas Control

## Distribution

US Distribution to state of: WV

## Key facts

- **Recall number:** Z-1057-2019
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-13
- **Report date:** 2019-04-03
- **Termination date:** 2020-04-14

- **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-1057-2019

## Citation

> AI Analytics. FDA recall Z-1057-2019. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1057-2019. Source: US FDA. Licensed CC0.

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