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Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Recalled October 9, 2024 · FDA recall Z-3305-2024 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
9783 kits
Sold at
Worldwide distribution - US Nationwide.
Description
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.
Product
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →