Randox Liquid Cardiac Control CQ5051 Recalled for Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5051 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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Randox Laboratories Ltd. is recalling 1,763 units of Liquid Cardiac Control, CQ5051. 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.
The recalled product was distributed to Indiana, New York, Puerto Rico, and West Virginia. This recall follows a previous recall issued by Randox on June 8, 2018, for a different lot of Liquid Cardiac Control CQ5053.
Consumers and healthcare facilities should stop using the affected product and contact Randox Laboratories for further instructions or a refund.
The recalled product
- Product
- Liquid Cardiac Control, CQ5051
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 1,763
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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