Radiometer Medical Aps: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Recall Summary Radiometer Medical ApS is recalling ABL90 FLEX and ABL90 FLEX PLUS blood analyzers used in hospitals and labs nationwide because they could produce inaccurate test results for blood gases and pH levels. The company is changing the device instructions, which sample types can be tested, the ranges for certain measurements, and adding new limitations and warnings. This is a Class II recall affecting medical facilities across all U.S. states.
- Recalling firm
- Radiometer Medical ApS
- Product
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-18
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/27b1e0bb-ce4d-48e2-a0bd-a72fec688e3f