Z-1594-2024Class II

Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

Name: Z-1594-2024 Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Creator: Randox Laboratories Ltd.
Published: 2024-01-31
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2024-01-31 / Open, Classified / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426 on 2024-01-31. FDA classified it as Class II and gives the reason as "Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1594-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-31
Posted: 2024-04-17
Recalling firm: Randox Laboratories, Limited
Product: Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Product code: DDZ Albumin, Fitc, Antigen, Antiserum, Control
Reason for recall: Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 6 units
Distribution: US Nationwide distribution in the states of GA, MA, WV including PR.
Product codes and lots: GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1594-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1593-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17
Z-1594-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17

Product code DDZ

K002674Class IIRandox MicroalbuminRandox Laboratories, Ltd. / cleared 2000-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)