FDA-Device2019-05-15Class II
Atellica Sample Handler Prime, Material Number 11069001
Hazard
There were multiple issues identified in the system software which required an update.
Sold states
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
Affected count
474
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica Sample Handler Prime, Material Number 11069001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1301-2019More Siemens Healthcare Diagnostics, Inc. recalls
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