This is an in vitro diagnostic product intended for use as… recallZ-2490-2019 · Randox Laboratories Ltd. · initiated Jul 12, 2019
Terminated
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
Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).
FDA root cause category: Under Investigation by firm
What the company is doing
Randox Laboratories Ltd. issued Urgent Medical Device Correction letter on 7/12/19 advising users of the problem, health risk and action to take: Replace all Quality Control value sheets with the revised sheets available on www.randox.com . Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to [email protected] within five working days.
Recall details
- Recall number
- Z-2490-2019
- Status
- Terminated
- Initiated by the company
- Jul 12, 2019
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 307 kits
- Product code
- JIX
- FDA submissions
- K053153
- Distribution
- Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Product description
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Code information (models, lots, serial numbers)
Lot Numbers: 961UE onwards GTN: 05055273200966
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CAL 3 CAL2351Randox Laboratories Limited · Calibrator, Multi-Analyte Mixture6 recalls0 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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