Calibration Serum Level 3. CAL 3, REF CAL2351. Human… recallZ-0751-2024 · Randox Laboratories Ltd. · initiated Nov 13, 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
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.
FDA root cause category: Under Investigation by firm
What the company is doing
On November 20, 2023, the firm notified customers via Medical Device Correction letter. The letter consisted of three parts. This recall record covers the third part, which concerned transcription errors in the Instructions for Use (IFU) for the above listed products. Customers should discard all copies of the IFUs and download the latest versions from www.randox.com. Customers should discuss the contents of the recall notice with their Medical Director if they have used the incorrect target value for any of the affected products.
Recall details
- Recall number
- Z-0751-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 13, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Product code
- JIX
- FDA submissions
- K053153
- Distribution
- US Nationwide distribution.
Product description
Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
Code information (models, lots, serial numbers)
UDI-DI: 05055273200966, lot1260UE, exp. 28 Nov 2024; lot 1262UE, exp. 28 Jan 2025; and lot 1315UE, exp. 28 May 2025
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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