Randox Laboratories: Medical Device Recall in 2018 - (Recall #: Z-0969-2018)

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 Controls (3x4x5mL and 12x5mL packages)

Product Classification:

Class III

Date Initiated: August 11, 2017

Date Posted: March 21, 2018

Recall Number: Z-0969-2018

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: 117 Kits

Code Information:

Catalog numbers: IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated