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Radiometer Medical ApS recalls Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-8
Recalled July 15, 2020 · FDA recall Z-2494-2020 · Radiometer Medical ApS
Hazard
Potential risk of patient mix-up on analyzers due to software issues. · FDA Class II
Units
3,899 units
Sold at
US - AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY. OUS - Australia, Austria, Canada, Czech Republic, China, Croatia, Denmark, France, Finland, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom
Description
Potential risk of patient mix-up on analyzers due to software issues.
Product
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.
Manufacturer(s)
Radiometer Medical ApS
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →