Recall Z-2446-2023— Randox Laboratories Ltd.

Name: FDA recall Z-2446-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-21

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-06-21. It names one FDA 510(k) clearance: K110904. 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. Reason: (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..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-21
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3Randox Laboratories, Ltd.·cleared 2011-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

(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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.