FDA-Device2022-04-20Class II
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
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
6606
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2022Don't want to check this manually?
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