Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-2490-2019)

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:

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

Product Classification:

Class III

Date Initiated: July 12, 2019

Date Posted: September 18, 2019

Recall Number: Z-2490-2019

Event ID: 83373

Reason for Recall:

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

Status: Terminated

Product Quantity: 307 kits

Code Information:

Lot Numbers: 961UE onwards GTN: 05055273200966

Distribution Pattern:

Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

Voluntary or Mandated:

Voluntary: Firm initiated