# FDA recall Z-2022-2023

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2023-05-04.

## Product

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes  Catalog Number:  IA2633

## Reason for recall

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

## Distribution

CA, IL, VA, WA, WI including PR

## Key facts

- **Recall number:** Z-2022-2023
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-04
- **Report date:** 2023-07-05

- **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-2022-2023

## Citation

> AI Analytics. FDA recall Z-2022-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2022-2023. Source: US FDA. Licensed CC0.

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