Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-0864-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 8, 2019

Date Posted: February 5, 2020

Recall Number: Z-0864-2020

Event ID: 84496

Reason for Recall:

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.

Status: Terminated

Product Quantity: 947

Code Information:

Software version 2.3.5 and below

Distribution Pattern:

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, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated