FDA-Device2020-07-15Class II

Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

Radiometer Medical ApS
Hazard

Potential risk of patient mix-up on analyzers due to software issues.

Sold states
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
Affected count
4,615 units
Manufactured in
Akandevej 21, Bronshoj, Denmark
Products
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and can be added to all models and configurations.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2493-2020

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