Randox Liquid Cardiac Control Level 3 Recalled for Precision Issues
Randox Laboratories is recalling Liquid Cardiac Control - Level 3 due to unacceptable variation between vials that may delay Troponin T test results.
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: The recall is classified as FDA Class II. The hazard involves a delay in reporting test results due to precision issues, which is a significant quality control concern but does not involve direct physical injury or death, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Randox Laboratories Ltd. is recalling Lot 4245CK of Liquid Cardiac Control - Level 3 (cat. no. CQ5053). This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. The recall involves 1 kit in the United States and 602 kits distributed outside the US.
The recall was initiated because the device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. This issue could lead to a delay in reporting Troponin T results if the quality control is reported as out of range. Operators may observe the quality control result for Troponin T falling outside range or increased imprecision for Quality Control monitoring.
The product was distributed worldwide, including in the US state of West Virginia and foreign countries such as Australia, Chile, China, Germany, Hungary, Ireland, Italy, Moldova, Netherlands, Peru, Poland, Saudi Arabia, Slovakia, Spain, Sultanate of Oman, UAE, UK, and Vietnam. Users should stop using the affected product and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
- Manufacturer
- Randox Laboratories Ltd.
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)
- Lot 4245CK.
Distribution
Distributed in 1 state:
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