Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-0839-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904

Product Classification:

Class II

Date Initiated: December 4, 2018

Date Posted: February 27, 2019

Recall Number: Z-0839-2019

Event ID: 81746

Reason for Recall:

Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.

Status: Terminated

Product Quantity: 225 kits

Code Information:

All lot codes

Distribution Pattern:

WV, PR

Voluntary or Mandated:

Voluntary: Firm initiated