Randox Liquid Urine Control Level 2- intended for in vitro… recallZ-2446-2023 · Randox Laboratories Ltd. · initiated Jun 21, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected] 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.

Recall details

Recall number: Z-2446-2023
Status: Open, Classified
Initiated by the company: Jun 21, 2023
Posted by the FDA: Aug 23, 2023
Recalling firm: Randox Laboratories Ltd.
Quantity: 39 units
Product code: JJY
FDA submissions: K110904
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

LIQUID URINE CONTROL - LEVEL 2 (LIQ URN CONTROL 2) UC5074
Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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