FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: 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
- Recall number
- Z-2446-2023
- Recalling firm
- Randox Laboratories Ltd.
- 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
- Status
- Open, Classified
- Initiated
- 2023-06-21
- Posted
- 2023-08-23
- Terminated
- not on file
- 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.
- 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 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.
- Quantity
- 39 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.
- Lot, serial or model codes
- GTIN: 05055273207569 Batch/Lot Number: 1209UC Expiry Date: 28 Mar 24
- 510(k) numbers
- K110904
- PMA numbers
- not on file
- Product code
- JJY
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28