Randox Liquid Cardiac Control CQ5053 Recalled for Shelf-Life Labeling Error
Randox is recalling 450 kits of Liquid Cardiac Control CQ5053 because the product does not meet its shelf-life claim, potentially causing test results to fall outside control ranges.
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 a voluntary precautionary recall for a labeling/shelf-life discrepancy in a quality control product. There are no reported injuries or illnesses, and the hazard is limited to potential test result variability, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Randox Laboratories, Limited is recalling 450 kits of Liquid Cardiac Control CQ5053, lot 4069CK. The product was distributed nationally. The recall was initiated because the Troponin T and Troponin I components in the quality control material do not meet the shelf-life claim stated on the product labeling.
Because the control material may now fall outside the provided control ranges, the product is being removed from the field. This issue affects the reliability of the quality control results rather than posing a direct physical hazard to patients or users.
Users of this specific lot should stop using the product and contact Randox Laboratories for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Liquid Cardiac Control CQ5053
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- Affected units
- 450
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 4069CK
Distribution
Distribution scope not specified by the agency.
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