Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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 Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24
Products Sold
GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of due to (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.
Recommended Action
Per FDA guidance
Randox Laboratories issued Medical Device Removal letter to the distribution center within the USA and P. Rico dated June 28, 2023. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " Review your inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review previous results for this controls and ensure patient results were not reported if control results were not within range. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026