Randox Liquid Cardiac Controls Recalled for N-proBNP Claim Removal
Randox Laboratories is removing N-proBNP claims from Liquid Cardiac Controls 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. The hazard involves a performance issue (decreased recovery) and claim removal rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for minor labeling or performance errors.
Plain-English summary
Randox Laboratories, Limited is recalling Randox Liquid Cardiac Controls, Catalogue Number CQ5052. The recall involves the removal of claims for N-proBNP (N-Terminal Pro-Brain Natriuretic Peptide) from the product.
The action was taken due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots. The affected units include 7,505 items distributed in the United States and various international locations.
The source text does not specify specific consumer actions beyond the recall notice itself, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- Randox Liquid Cardiac Controls Catalogue Number CQ5052.
- Manufacturer
- Randox Laboratories, Limited
- Affected units
- 7,505
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 (3)
- 4247CK (Exp. 28Nov2019)
- 4261CK (Exp. 28Nov2019)
- 4312CK Exp. 28Jun2020) and 4315CK (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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