Randox Liquid Urine Control Level 3 Recalled for Labeling Error
Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3 due to a labeling error affecting Total Protein values.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error that does not affect product performance or stability.
Plain-English summary
Randox Laboratories is recalling 198 kits of Liquid Urine Control Level 3, a product used for quality control monitoring of in-vitro diagnostic urinary clinical assays. The recall is due to a labeling error identified during an investigation.
The error affects the mean values for two test methods used to quantify Total Protein (urine), which are incorrect by a factor of 10. Instrument-specific values remain correct, and the error does not affect the performance or stability claims of the product. This discrepancy may cause control results to fall outside the quoted range, potentially leading to a delay in reporting sample test results, though this is unlikely as correct instrument-specific means are included in the value sheet.
The product was distributed worldwide, including to Puerto Rico and various countries such as Canada, Kuwait, Chile, Poland, China, Romania, France, Saudi Arabia, Guatemala, Slovenia, Iran, UAE, India, UK, Italy, Uruguay, and Iraq. Customers have been referred to their Medical Director for further advice.
The recalled product
- Product
- Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
- Manufacturer
- Randox Laboratories
- Hazard
- Affected units
- 198
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)
- Catalogue number UC5075 Batch number 907UC
Distribution
Distributed in 1 state:
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