FDA-Device2021-11-03Class II
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Siemens Healthcare Diagnostics, Inc.
Hazard
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Sold states
Worldwide distribution - US Nationwide distribution.
Affected count
1402 (US); 2941 (OUS)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2022Don't want to check this manually?
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