# FDA recall Z-0413-2020

> **Randox Laboratories, Limited** · Class II · device recall initiated 2019-10-04.

## Product

Randox Liquid Cardiac Controls Catalogue Number CQ5052.

## Reason for recall

Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.

## Distribution

US Distribution: WV, CA, DE, NJ, NY, GA, IN, PR  OUS Distribution: CA, PL, CH, JP, NL, IT, CN, GB, IE, RU, MD, BY, SA, VN, AE, BH, DK, CO, ES, FR, TW, PH, TH, OM, HU, IN, KR, ZA, AU, CZ, PE, CL, IR, NZ, BE, DE, BA, SV, SK, HK, PT, PK, BR, TR, UA, SE, QA, LT, PE,

## Key facts

- **Recall number:** Z-0413-2020
- **Recalling firm:** Randox Laboratories, Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-04
- **Report date:** 2019-11-27
- **Termination date:** 2020-07-06

- **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-0413-2020

## Citation

> AI Analytics. FDA recall Z-0413-2020. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0413-2020. Source: US FDA. Licensed CC0.

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