Clinical Chemistry Calibration Serum (Catalog number… recallZ-1759-2024 · Randox Laboratories Ltd. · initiated Mar 5, 2024
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
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
FDA root cause category: Process design
What the company is doing
Consignees were emailed a Medical Device Correction notice dated 3/5/2024 instructing them to discuss the contents of the notification with their facility's Medical Director if affected units have been used, replace the IFU for affected devices with the one provided with the notification, and complete and return the provided response form by email to technical [email protected] within five working days. Updated IFUs can be accessed at www.randox.com and questions can be directed to [email protected].
Recall details
- Recall number
- Z-1759-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 5, 2024
- Posted by the FDA
- May 3, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 80,366 units (US: 242 units; OUS: 80,094 units)
- Product code
- JIX
- FDA submissions
- K053153
- Distribution
- Domestic: Nationwide Distribution.
Product description
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
Code information (models, lots, serial numbers)
Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.
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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