FDA-Device2024-10-09Class II
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Siemens Healthcare Diagnostics, Inc.
Hazard
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Sold states
Worldwide distribution - US Nationwide.
Affected count
5622 kits
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3304-2024Don't want to check this manually?
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