Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1594-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 31, 2024

Date Posted: April 24, 2024

Recall Number: Z-1594-2024

Event ID: 94138

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%.

Status: Ongoing

Product Quantity: 6 units

Code Information:

GTIN: 05055273204544 (1) Batch/Lot: 602114 /1083MA-1087MA (2) Batch/Lot: 636645 /1108MA-1112MA (3) Batch/Lot: 662429 /1083MA- 1087MA

Distribution Pattern:

US Nationwide distribution in the states of GA, MA, WV including PR.

Voluntary or Mandated:

Voluntary: Firm initiated