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
This recall is currently active, issued August 23, 2023. It was issued by Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland.
- Recall Initiated
- June 21, 2023
- Posted
- August 23, 2023
- Recall Number
- Z-2446-2023
- Quantity
- 39 units
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
Lot / Code Info
GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24
Root Cause
Under Investigation by firm
Action Taken
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 technical.services@randox.com 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.