Luminex Corporation recalls ARIES System and ARIES M1 System

Recall date

April 19, 2017

Source

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

Recall number

Z-2094-2017

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of Finland and China.

Why it was recalled

The hand-held barcode scanner that is used as an accessory to enter ARIES cassette and specimen identifications on the ARIES Systems populates patient sample IDs with a previously scanned sample ID when entering orders into an ARIES instrument.

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

What was recalled

ARIES System and ARIES M1 System