FDA-Device2019-08-28Class II
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Radiometer America Inc
Hazard
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
Sold states
US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico
Affected count
13,042 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2019Don't want to check this manually?
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