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

Recalled March 21, 2018 · FDA recall Z-0970-2018 · Randox Laboratories

Hazard

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

Units

199 Kits

Sold at

Distribution US nationwide.

Description

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

Product

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

Manufacturer(s)

Randox Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →