The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

Class II

Recalling firm: Radiometer Medical ApS
Reason for recall: In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
Affected products (lot / model / serial): UDI-DI: 05700693930923, 05700693930909 Software versions 3.6 and lower. ABL90 FLEX PLUS Instructions for Use versions prior to: 996-223, Version: 202606O. ABL90 FLEX Instructions for Use versions prior to: 996-189, Version: 202606L
Units affected: 5395
Distribution pattern: US Nationwide distribution including in the states of CA, OH, LA, MA, FL, NY, CO, IL, TX, GA, NC, PA, SC, MI, OK, WI, AR, MN, OR, UT, WA, SD, IN, TN, AZ, NE, WY, KY, AL, AK, ID, NJ, DE, MT, CT, MS, MO, VT, WV, IA, MD, KS, DC, NV, VA, NM, NH, ND, ME, HI, RI.
Firm location: Bronshoj, Denmark
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-0190-2027
Recall initiated: August 18, 2026
FDA classification date: October 15, 2026
FDA report date: October 21, 2026
FDA event ID: 99772
Last updated on HTM Vibe: October 27, 2026