Randox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values
Randox Laboratories is recalling Chemistry QC Premium Plus due to incorrect Sodium target values. The error affects quality control accuracy for diagnostic assays.
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. The hazard involves incorrect quality control values which may impact diagnostic accuracy, but no direct patient injury or illness is reported in the source text, fitting the criteria for moderate severity.
Plain-English summary
Randox Laboratories Ltd. is recalling Chemistry QC Premium Plus, Catalog No. LAL4213, GTIN 05055273209006. The recall involves 186 total units, with 27 units distributed in the United States. The product is intended for in vitro diagnostic use specifically for the quality control of diagnostic assays to control accuracy.
The recall was initiated because the control target and range value for Sodium using the ISE indirect method was assigned incorrectly. This error may affect the accuracy of quality control results for Sodium measurements in diagnostic laboratories.
The affected product is Lot 306UL. Distribution was worldwide, including US nationwide distribution in the states of WV, IN, VA, ID, PR, and DE, as well as in countries including the West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, and UK. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
- Manufacturer
- Randox Laboratories Ltd.
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)
- Lot 306UL
Distribution
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