FDA-Device2022-04-20Class II
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Siemens Healthcare Diagnostics, Inc.
Hazard
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Sold states
Global Distribution. US Nationwide.
Affected count
199
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2022Don't want to check this manually?
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