Randox Laboratories Ltd. recalls G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitr…

Recall date

April 3, 2019

Source

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

Recall number

Z-1255-2019

FDA classification

Class II

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

Why it was recalled

The target values and ranges in these lots are incorrect.

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

What was recalled

G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes