Class IIDeviceOngoing

Radiometer Medical ApS

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.

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.

Details

Recall number: Z-0190-2027
Event ID: 99772
Recall initiated: Aug 18, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 5395
Distribution: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Bronshoj, Denmark
Lot / code info: 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