Radiometer Medical ApS recalls Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-8

Recalled July 15, 2020 · FDA recall Z-2493-2020 · Radiometer Medical ApS

Hazard

Potential risk of patient mix-up on analyzers due to software issues. · FDA Class II

Units

4,615 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 393-800; 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.

Manufacturer(s)

Radiometer Medical ApS

Made in

Denmark

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →