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

Recall Z-0762-2017 — The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homo

U.S. FDA — Device Enforcement · United Kingdom · 2016-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0762-2017
Date of alert: 2016-09-16
Country / jurisdiction: United Kingdom
Risk level: Class II
Risk type: recall
Brand: Randox Laboratories
Product category: device
Product type: Devices

Reported risk: An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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