Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0412-2020 — Randox Liquid Cardiac Controls Catalogue Number CQ5051

U.S. FDA — Device Enforcement · United Kingdom · 2019-10-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0412-2020
Date of alert
2019-10-04
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories, Limited
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273207446
Reported risk: Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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