Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Recall date

August 3, 2023

Source

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

Recall number

Z-2609-2023

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

US States: GA, OH, OR, PA, TX, VA

Why it was recalled

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215