Z-0762-2017Class II

The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB...

Name: Z-0762-2017 The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB...
Creator: Randox Laboratories
Published: 2016-09-16
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2016-09-16 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories began a recall of 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... on 2016-09-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0762-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Posted: 2016-12-14
Terminated: 2018-04-11
Recalling firm: Randox Laboratories, Limited
Product: 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.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 2817
Distribution: Worldwide Distribution - US Distribution.
Product codes and lots: CQ5053 CQ5052

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0762-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0762-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code JJY

K110534Class IRandox Liquid Cardiac Control Levels 1, 2 and 3Randox Laboratories Limited / cleared 2012-01-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)