Skip to content
Recall Observatory FDA recall evidence

Device product

ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.

Z-1119-2013

March 13, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 64610
Status
Terminated
Classification
Class II
Quantity
3871
Official record key
device-enforcement:Z-1119-2013

Official wording

Reason: Negative bias in patient samples for Vitamin D

Code information: Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Negative bias in patient samples for Vitamin D