Randox Laboratories: Medical Device Recall in 2018 - (Recall #: Z-0970-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)

Product Classification:

Class III

Date Initiated: August 11, 2017

Date Posted: March 21, 2018

Recall Number: Z-0970-2018

Event ID: 79076

Reason for Recall:

The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

Status: Terminated

Product Quantity: 199 Kits

Code Information:

Catalog numbers: IA3109 (Lots: 1476EC, 1573EC, 1619EC) IA3110 (Lots 1477EDC, 1599EDC, 1621EC, 1662EC) IA3111 (Lots: 1478EC, 1508EC, 1578EC, 1647EC) IA3112 (Lots: 359199, 377412, 373302, 382147, 382679, 395668, 416979)

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated