Randox Laboratories Ltd.: Medical Device Recall in 2021 - (Recall #: Z-2099-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115

Product Classification:

Class II

Date Initiated: May 10, 2021

Date Posted: July 28, 2021

Recall Number: Z-2099-2021

Event ID: 88130

Reason for Recall:

Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples

Status: Terminated

Product Quantity: 71 kits US

Code Information:

Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066

Distribution Pattern:

US Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX

Voluntary or Mandated:

Voluntary: Firm initiated