Z-2446-2023Class II

Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase...

Name: Z-2446-2023 Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase...
Creator: Randox Laboratories Ltd.
Published: 2023-06-21
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-06-21 / Open, Classified / root cause: labeling and UDI

FDA source

Randox Laboratories Ltd. began a recall of Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose... on 2023-06-21. FDA classified it as Class II and gives the reason as "(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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2446-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-21
Posted: 2023-08-23
Recalling firm: Randox Laboratories, Limited
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
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 39 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
Product codes and lots: GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2446-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2446-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-23

Product code JJY

K110904Class IRandox Liquid Urine Control Levels 2 and 3Randox Laboratories, Ltd. / cleared 2011-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)