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Randox Laboratories Ltd. recalls Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, C
Recalled August 30, 2023 · FDA recall Z-2446-2023 · Randox Laboratories
Hazard
(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. · FDA Class II
Units
39 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
Description
(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.
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
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →