Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1105-2019)

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:

Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

Product Classification:

Class III

Date Initiated: February 7, 2019

Date Posted: April 17, 2019

Recall Number: Z-1105-2019

Event ID: 82184

Reason for Recall:

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

Status: Terminated

Product Quantity: 58

Code Information:

Lot codes: 440941 1720EC

Distribution Pattern:

The products were distributed to the following US states: WV and Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated