The Recall Desk
ModerateFDA (Devices)·Z-0413-2020·Announced 2019-11-27

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.

What this means for you

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.
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

Distributed in 8 states:

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.

See all 3 products in this recall →