# FDA recall Z-2207-2019

> **Randox Laboratories, Limited** · Class III · device recall initiated 2019-06-10.

## Product

Assayed Bovine Multi-Sera Level 1, Model No. AL1027

## Reason for recall

The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

## Distribution

Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

## Key facts

- **Recall number:** Z-2207-2019
- **Recalling firm:** Randox Laboratories, Limited
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-10
- **Report date:** 2019-08-14
- **Termination date:** 2020-06-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2207-2019

## Citation

> AI Analytics. FDA recall Z-2207-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2207-2019. Source: US FDA. Licensed CC0.

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