Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Recalled by Radiometer Medical ApS Due to ABL90 FLEX and ABL90 FLEX PLUS analyzers running...

Date: March 21, 2025
Company: Radiometer Medical ApS
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer Medical ApS directly.

Affected Products

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.

Quantity: 6275 analyzers

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 48 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC

Affected (48 states)Not affected

About Radiometer Medical ApS

Radiometer Medical ApS has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report