Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Blood gases (PCO2 Recalled by Radiometer Medical ApS Due to Potential risk of patient mix-up on analyzers due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer Medical ApS directly.
Affected Products
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
Quantity: 3,899 units
Why Was This Recalled?
Potential risk of patient mix-up on analyzers due to software issues.
Where Was This Sold?
This product was distributed to 46 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC
About Radiometer Medical ApS
Radiometer Medical ApS has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report