Radiometer America Inc recalls ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Recall date

July 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2320-2019

FDA classification

Class II

Brand / firm

Radiometer America Inc

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909