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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.

Z-1120-2013

March 13, 2013

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 64610
Status
Terminated
Classification
Class II
Quantity
4133
Official record key
device-enforcement:Z-1120-2013

Official wording

Reason: Negative bias in patient samples for Vitamin D

Code information: Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 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