# FDA recall Z-0969-2018

> **Randox Laboratories** · Class III · device recall initiated 2017-08-11.

## Product

Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)

## Reason for recall

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

## Distribution

Distribution US nationwide.

## Key facts

- **Recall number:** Z-0969-2018
- **Recalling firm:** Randox Laboratories
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-11
- **Report date:** 2018-03-21
- **Termination date:** 2019-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kearneysville, WV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0969-2018

## Citation

> AI Analytics. FDA recall Z-0969-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0969-2018. Source: US FDA. Licensed CC0.

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