Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1017-2019)

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:

Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Product Classification:

Class II

Date Initiated: December 3, 2018

Date Posted: March 27, 2019

Recall Number: Z-1017-2019

Event ID: 81783

Reason for Recall:

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Status: Ongoing

Product Quantity: 141 kits

Code Information:

499FR

Distribution Pattern:

US Distribution to states to: CA, ME. MI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated