Calibration Serum Level 3 recallZ-0752-2024 · Randox Laboratories Ltd. · initiated Nov 20, 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
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
FDA root cause category: Under Investigation by firm
What the company is doing
Randox issued Urgent Medical Device Correction Letter via email to the US and PR Distributors on 11/20/23. Distributors contacted the customer directly. The Letter states reason for recall, health risk and action to take: Action to be taken: " Discuss the contents of this notice with your Medical Director if you have used the RX Series targets for CK Total in the aforementioned lots. " Complete and return the response form, 12187-QA to [email protected] within five working days. " Please discard all copies of the IFUs and download the latest versions from www.randox.com. If you have any questions or concerns please contact Randox Technical Services.
Recall details
- Recall number
- Z-0752-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 20, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 269 kits
- Product code
- JIX
- FDA submissions
- K053153
- Distribution
- US Nationwide and Puerto Rico.
Product description
Calibration Serum Level 3 CAL2351
Code information (models, lots, serial numbers)
GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE
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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