Device recall
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.
- Recall number
- Z-0190-2027
- Event id
- 99772
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Radiometer Medical ApS
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Oct 15, 2026
- Product code
- CHL
- Device type
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Reason
- 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.
- Root cause
- No Marketing Application
- Quantity
- 5395
- 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
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K041874
- Location
- Bronshoj, Denmark