Reported Aug 30, 2023 · Ongoing
Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium,…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- 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 NumberUC5074
- Lot codes and dates
- GTIN05055273207569
- Batch/Lot Number1209UC
- Expiry Date28 Mar 24
- Amount recalled
- 39 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
(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.
This product could cause temporary or reversible health problems — stop using it.
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