Randox Laboratories Ltd. recalls IgE Calibrator Series

Recall date

September 7, 2016

Source

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

Recall number

Z-0050-2017

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

All consignees are in the US.

Why it was recalled

According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.

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

What was recalled

IgE Calibrator Series