Radiometer Medical ApS recalls AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: T…

Recall date

August 8, 2019

Source

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

Recall number

Z-0864-2020

FDA classification

Class II

Brand / firm

Radiometer Medical ApS

Sold / distributed

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of:  Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, Franc…

Why it was recalled

The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

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

What was recalled

AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.