Home / Recalls / Radiometer Medical ApS / Z-1394-2023

Z-1394-2023 Class II Ongoing

Recalled by Radiometer Medical ApS — Bronshoj, N/A

FDA device recall Z-1394-2023 was initiated by Radiometer Medical ApS on March 8, 2023 and is designated Class II. Reason for recall: Due to potential software issue that may result in patient mix-up information. The recall status is ongoing. Affected quantity: 1,806 systems.

Recall Details

Product Type
Devices
Report Date
April 26, 2023
Initiation Date
March 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,806 systems

Product Description

AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

Reason for Recall

Due to potential software issue that may result in patient mix-up information.

Distribution Pattern

Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.

Code Information

Model Number: 933-599 UDI-DI Code: 05700699335999 Software Versions: 2.5.2 and above (Versions 2.5.2, 2.5.3, 2.5.4, 2.60, and 2.6.1)

Other recalls by Radiometer Medical ApS

  • Z-1659-2025 Class II — Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiomet (March 21, 2025)
  • Z-2426-2024 Class II — ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are (May 31, 2024)
  • Z-1321-2022 Class II — ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 (May 18, 2022)
  • Z-1115-2022 Class II — Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrol (April 8, 2022)
  • Z-1858-2021 Class II — E3800 PC Units (spare parts) (April 14, 2021)
  • Z-1857-2021 Class II — Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is als (April 14, 2021)
  • Z-1856-2021 Class II — Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also use (April 14, 2021)
  • Z-1683-2021 Class II — PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyt (March 26, 2021)
  • Z-2493-2020 Class II — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393- (May 26, 2020)
  • Z-2494-2020 Class II — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393- (May 26, 2020)

FDA data resources