Randox Laboratories Ltd. recalls Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

Recall date

December 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1100-2020

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.

Why it was recalled

A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml