Microalbumin Calibrator Series (mALB CAL)-IVD used to… recallZ-1593-2024 · Randox Laboratories Ltd. · initiated Jan 31, 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
Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
FDA root cause category: Under Investigation by firm
What the company is doing
Randox Laboratories (Manufacturer) issued Urgent Field Safety Notice on 31 Jan 24 Complaint Reference: REC716 letter via email to Distributors. Distributors will contact the end-users. Letter states reason for recall, health risk and action to take: We have reassigned the target values in the above lot numbers in line with the ERM reference material. Please refer to the table below for the updated calibrator targets. You may experience a shift in Quality Control and patient sample recovery of up to +12%. Please discard all copies of the calibrator Instructions For Use (IFU)s and download the updated IFUs from www.randox.com . If further information is required, please contact [email protected] . In line with the restandardisation to the Microalbumin Calibrator Series, we are updating the target and range for the Microalbumin Liquid control, MA1361, lots 1102MA and 1103MA which are present in batch 631698. The updated targets and ranges can be found in the table below. Please discard any copies of the IFU and download the updated version from www.randox.com.
Recall details
- Recall number
- Z-1593-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 31, 2024
- Posted by the FDA
- Apr 17, 2024
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 8 units
- Product code
- JIT
- Distribution
- US Nationwide distribution in the states of GA, MA, WV including PR.
Product description
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Code information (models, lots, serial numbers)
GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MICROALBUMIN CALIBRATOR SERIES (mALB CAL) MA1567Randox Laboratories Limited · Calibrator, Secondary1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94138).
- Z-1594-2024 · Open, ClassifiedMicroalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
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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