Randox Liquid Urine Control Level 2 Recalled for Analytical Accuracy Issues
Randox Liquid Urine Control Level 2 (Lot 1209UC) is recalled for incorrect hCG and cortisol values and a transcription error in instructions. The defects may delay patient test reporting.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported illnesses or injuries. The hazard is analytical accuracy failure in a quality control product, which poses risk of undetected equipment malfunction and potentially unreliable patient test results, but no direct patient harm has been reported. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Liquid Urine Control Level 2 (Catalog Number UC5074, Lot 1209UC, expires 28 March 2024). This product is an in vitro diagnostic control material used in clinical laboratories to verify the accuracy of urine chemistry analyzer measurements.
The recall addresses three manufacturing and labeling defects: vial-to-vial variation causing some control vials to incorrectly show positive results for human chorionic gonadotropin (hCG) when they should be negative; cortisol measurements that are high and outside acceptable ranges; and a transcription error in the Instructions for Use that incorrectly specifies target values and acceptable ranges for creatinine testing on Roche chemistry systems. These defects compromise the reliability of quality control checks for these analytes.
The affected product was distributed worldwide, including in the United States in Arkansas, Florida, Georgia, Ohio, Virginia, and Puerto Rico. Clinical laboratories using this lot of control material may experience delays in reporting patient test results.
Laboratories should stop using this lot immediately and contact the manufacturer regarding replacement. If this control material was used to validate laboratory equipment, facilities should evaluate the reliability of quality control results obtained with this lot.
The recalled product
- Product
- Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- analytical-inaccuracy
- transcription-error
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)
- GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24
Distribution
Distributed nationwide across the United States.
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