Randox Liquid Cardiac Control Recalled for Potential Concentration Decrease
Randox Laboratories is recalling specific lots of Liquid Cardiac Control due to potential decreased NTproBNP concentration readings on Siemens Dimension EXL LOCI analyzers.
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, but the source text describes a potential decrease in concentration readings without reporting any patient injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Randox Laboratories Ltd. is recalling 11,420 kits of Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, and CQ5053. The affected lots are 4243CK, 4244CK, and 4245CK. The product was distributed to California, Delaware, West Virginia, and Puerto Rico.
The recall was initiated because customers may observe a decrease in recovered concentration regarding NTproBNP when using these specific control lots on the Siemens Dimension EXL LOCI analyzer. This issue may affect the accuracy of the control results.
Healthcare facilities and laboratories that have received these specific lots should stop using them and contact Randox Laboratories for further instructions or a replacement.
The recalled product
- Product
- Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 11,420
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)
- lots 4243CK
- 4244CK
- 4245CK.
Distribution
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