# FDA recall Z-1563-2021

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2021-03-29.

## Product

Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator.   Catalogue Number: CAL2351

## Reason for recall

Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bilirubin instability in the calibrator and is evident in both Quality Control (QC) and Patient samples.

## Distribution

Domestic: IN, MA, CA, NJ, TX, NE, NY, VA, MD, MN, OR, IL, CT, DC, MS. Foreign: Albania, Argentina, Australia, Bangladesh, Bolivia, Bosnia & Herzegovina, Cameroon, Canada, Colombia, Cyprus, Denmark, Egypt, Estonia, Fiji, France, Germany, Greece, Hong Kong, Iraq, Italy, Ireland, Jordan, Kazakhstan, Kenya, Lithuania, Luxembourg, Mauritius, Mexico, Myanmar, Nepal, New Zealand, Pakistan, Palestine, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, The Netherlands, Turkey, UK, Ukraine, USA, and Vietnam.

## Key facts

- **Recall number:** Z-1563-2021
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-29
- **Report date:** 2021-05-19
- **Termination date:** 2021-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1563-2021

## Citation

> AI Analytics. FDA recall Z-1563-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1563-2021. Source: US FDA. Licensed CC0.

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