# FDA recall Z-2150-2019

> **Randox Laboratories, Limited** · Class II · device recall initiated 2019-06-11.

## Product

Human Assayed Multi-Sera Level 2, Model NO. HN1530    Product Usage:  This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

## Reason for recall

The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

## Distribution

US Nationwide Distribution -   AZ  CA  CT  FL  GA  IL  KY  LA  MA  MD  MI  MN  MO  NJ  NY  OH  OK  OR  PA  TX  UT  VA  WA  WI  WV and PR. Worldwide foreign distribution.

## Key facts

- **Recall number:** Z-2150-2019
- **Recalling firm:** Randox Laboratories, Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-11
- **Report date:** 2019-08-14
- **Termination date:** 2020-05-15

- **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-2150-2019

## Citation

> AI Analytics. FDA recall Z-2150-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2150-2019. Source: US FDA. Licensed CC0.

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