FDA-Device2020-03-11Class II
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Siemens Healthcare Diagnostics, Inc.
Hazard
Some lots ending in "17", "18", "19", or higher may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette, which may falsely elevate or depress sample results.
Sold states
Domestic distribution nationwide. Worldwide foreign distribution.
Affected count
3559
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1421-2020Don't want to check this manually?
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