Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5052 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. The hazard involves unacceptable variation in a control product, which is a quality issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or quality defects.
Plain-English summary
Randox Laboratories Ltd. is recalling 1,738 units of Liquid Cardiac Control, CQ5052. 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 affected product was distributed to Indiana, New York, Puerto Rico, and West Virginia. This recall follows a previous recall issued by Randox for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The current recall covers all lots of CQ5051, CQ5052, and CQ5053.
Users of this product should stop using it for the Troponin T assay and contact the manufacturer for further instructions.
The recalled product
- Product
- Liquid Cardiac Control, CQ5052
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 1,738
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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