Recall Z-1659-2025— Radiometer Medical ApS

Name: FDA recall Z-1659-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Class II · Ongoing

Class II FDA medical device recall by Radiometer Medical ApS, initiated 2025-03-21. It names 2 FDA 510(k) clearances: K160153, K092686. Product: Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.. Reason: ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results..

Recalling firm: Radiometer Medical ApS
Classification: Class II
Status: Ongoing
Initiated: 2025-03-21
Firm location: Bronshoj, N/A, Denmark

510(k) clearances named in this recall

2 on FDA's record

K160153 — ABL90 FLEX PLUSRadiometer Medical Aps·cleared 2016-11-04
K092686 — ABL90 FLEX SERIESRadiometer Medical Aps·cleared 2010-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.

Reason for recall

ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.