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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)

Z-0130-2015

October 09, 2012

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc
Event
Event 69449
Status
Terminated
Classification
Class II
Quantity
234 kits
Official record key
device-enforcement:Z-0130-2015

Official wording

Reason: Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system

Code information: Lot numbers: 83496A22 88716A22 95040822 95889A22 Exp. 01/19/2013

Distribution pattern: Worldwide Distribution - Nationwide Distribution and the countries of Argentina, Australia, Brazil, Canada, China, Columbia, Egypt, Hong Kong, India, Israel, Indoenesia, India, Japan, Korea, Mexico, Malaysia, Philippines, Saudi Arabia, Singapore, Taipei, Uruguay, Venezuela, Viet Nam and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system