Randox Recalls Liquid Cardiac Control CQ5053 Due to Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a quality defect (unacceptable variation) rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is recalling 2,108 units of Liquid Cardiac Control, CQ5053. The firm has confirmed that the product is no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
This recall affects all lots of the product. The affected units were distributed to Indiana, New York, Puerto Rico, and West Virginia. Randox previously issued a recall for a specific lot of this product in June 2018.
Consumers and healthcare facilities should stop using the affected product and contact Randox Laboratories for further instructions.
The recalled product
- Product
- Liquid Cardiac Control, CQ5053
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 2,108
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)
- All lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Randox Laboratories Ltd. 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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