Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is recalling Liquid Cardiac Controls (CQ5051) 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 corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls, Catalogue Number CQ5051. The recall involves 6,208 units distributed in the United States and internationally.
The recall is initiated to remove claims for N-proBNP from the product. This action is taken due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. The affected lots include 4243CK, 4246CK, 4249CK, 4260CK, 4311CK, and 4317CK.
The product was distributed in the US states of WV, CA, DE, NJ, NY, GA, IN, and PR, as well as in numerous countries outside the US. Consumers and healthcare facilities should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Randox Liquid Cardiac Controls Catalogue Number CQ5051
- Manufacturer
- Randox Laboratories, Limited
- Hazard
- Affected units
- 6,208
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 (5)
- 4246CK (Exp. 28Nov2019)
- 4249CK (Exp. 28Nov2019)
- 4260CK (Exp. 28Nov2019)
- 4311CK (Exp. 28May2020)
- 4317CK (Exp. 28May2020)
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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