FDA-Device2019-08-28Class II
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Siemens Healthcare Diagnostics, Inc.
Hazard
Iincreased (falsely elevated) Albumin results compared to expected results
Sold states
Nationwide
Affected count
664 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2341-2019Don't want to check this manually?
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