Calibration Serum Level 3 - IVD For use as a Calibrator in… recallZ-0753-2024 · 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
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
FDA root cause category: Under Investigation by firm
What the company is doing
Randox issued Urgent Medical Device Correction letter on 11/20/23 to the distribution center within the USA. The US distributor contacted the customer direct via email. Letter states reason for recall, health risk and action to take: Review your calibrator inventory of this lot and assess your laboratories needs for reimbursement for discarded inventory. " 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. If you have any questions or concerns please contact Randox Technical Services.
Recall details
- Recall number
- Z-0753-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 20, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 108 kits
- Product code
- JIX
- FDA submissions
- K053153
- Distribution
- US Nationwide including Puerto Rico.
Product description
Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
Code information (models, lots, serial numbers)
GTIN: 05055273200966 Lot/Batch No: 1214UE Exp. Date: 28 Nov 2023
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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