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, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
FDA Recall Z-0762-2017 · Posted None
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Recalling FirmRandox Laboratories
Recall StatusTerminated
Product CodeJJY
Date Initiated2016-09-16
Date Terminated2018-04-11
Product Quantity2817
Reason for Recall
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.
Firm Action
Randox sent an Urgent Field Safety Notice dated September 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Please note the control value sheets have been updated with the new values. A FSN has been completed to advise customers on the appropriate action to take.
For further questions, please call (304) 728-2890.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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