Luminex Corporation recalls Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Sca…

Recall date

June 29, 2018

Source

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

Recall number

Z-2292-2019

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

Worldwide distribution. US nationwide, Canada, Ireland, Netherlands, Singapore, Thailand, and United Kingdom

Why it was recalled

An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could result in sample/patient mismatch or duplicate results (from other patients specimens) for a patient order.

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

What was recalled

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017