Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-0660-2019)

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:

SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

Product Classification:

Class II

Date Initiated: November 19, 2018

Date Posted: January 2, 2019

Recall Number: Z-0660-2019

Event ID: 81664

Reason for Recall:

Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.

Status: Terminated

Product Quantity: 250 kits (32 kits US / 218 kits OUS)

Code Information:

05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019

Distribution Pattern:

US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.

Voluntary or Mandated:

Voluntary: Firm initiated