Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2446-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: June 21, 2023

Date Posted: August 30, 2023

Recall Number: Z-2446-2023

Event ID: 92710

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.

Status: Ongoing

Product Quantity: 39 units

Code Information:

GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.

Voluntary or Mandated:

Voluntary: Firm initiated