FDANovember 19, 2015device
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Systems. This could lead, under certain circumstances, to an erroneously increased result with a Factor VIII Chromogenic Assay.
What to do
FDA enforcement status: Terminated
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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