Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is recalling Liquid Cardiac Controls (CQ5053) to remove N-proBNP claims due to decreased recovery in recent lots.
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, which typically indicates a temporary or medically reversible adverse health consequence. The issue is a performance deviation (decreased recovery) leading to claim removal, without reported injuries or illnesses.
Plain-English summary
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls, Catalogue Number CQ5053. The recall involves 6,702 units distributed in the United States (WV, CA, DE, NJ, NY, GA, IN, PR) and internationally. The affected lots are 4245CK, 4248CK, 4313CK, and 4316CK.
The recall is being conducted to remove claims for N-proBNP from the product. This action is due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. The agency has classified this as a Class II recall.
Users of these products should stop using the affected lots and contact Randox Laboratories for further instructions or a replacement.
The recalled product
- Product
- Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
- Manufacturer
- Randox Laboratories, Limited
- Affected units
- 6,702
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 (2)
- 4248CK (Exp. 28Nov2019)
- 4313CK (Exp. 28Jun2020) and 4316CK (Exp. 28Jun2020)
Distribution
Part of a larger recall action
This product is one of 3 recalled by Randox Laboratories, Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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