TemporaryFDAOngoing
Can cause harm that is usually temporary.
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.
Check the device or its packaging for
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
- Why
- 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.
- Distributed
- 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.
- Company
- Radiometer Medical ApS
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0190-2027 · retrieved 15 October 2026
Read the official notice