FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Recall number
- Z-1593-2024
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
- Status
- Open, Classified
- Initiated
- 2024-01-31
- Posted
- 2024-04-17
- Terminated
- not on file
- Reason
- 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%.
- Root cause
- Under Investigation by firm
- Action
- 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 technical.services@randox.com . 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.
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of GA, MA, WV including PR.
- Lot, serial or model codes
- GTIN: 05055273204520 (1) Batch/Lot: 619282 / 1094MA-1098MA
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28