# FDA recall Z-1100-2020

> **Randox Laboratories Ltd.** · Class III · device recall initiated 2019-12-13.

## Product

Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

## Reason for recall

A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).

## Distribution

US: NY and DE    OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.

## Key facts

- **Recall number:** Z-1100-2020
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-13
- **Report date:** 2020-02-12
- **Termination date:** 2020-10-02

- **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-1100-2020

## Citation

> AI Analytics. FDA recall Z-1100-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1100-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*