Randox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery
Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, 2, and 3 because internal stability monitoring revealed decreased recovery of myoglobin and CKMB.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a quality control device where the hazard is a potential for inaccurate test results due to decreased analyte recovery, without reported patient injuries or illnesses.
Plain-English summary
Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3. These liquid controls are intended for the quality control of various cardiac assays, including BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T, on clinical chemistry and immunoassay systems. The product is intended for prescription use only.
The recall was initiated after an internal real-time stability monitoring program revealed decreased recovery of specific analytes. Specifically, the monitoring showed a -20% bias in myoglobin recovery for Randox Immunoturbidimetric and Siemens Centaur Classic methods. Additionally, a -21% bias in CKMB recovery was observed for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
A total of 2,817 units were distributed worldwide, including in the United States. Affected lots include codes CQ5053 and CQ5052. Users of these in vitro diagnostic devices should stop using the affected controls and contact Randox Laboratories for further instructions.
The recalled product
- 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…
- Manufacturer
- Randox Laboratories
- Hazard
- Affected units
- 2,817
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- CQ5053 CQ5052
Distribution
Distribution scope not specified by the agency.
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