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Recall Observatory FDA recall evidence

Device product

Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency

Z-0468-2016

November 19, 2015

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 72752
Status
Terminated
Classification
Class II
Quantity
Domestic: 52 kits, Foreign: 623 kits
Official record key
device-enforcement:Z-0468-2016

Official wording

Reason: 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.

Code information: Lot Number 44637, exp. 2016-11-30

Distribution pattern: Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.