RegWardenFDA facility compliance records
Recall

Class III — Siemens Healthcare Diagnostics, Inc

Recalling firmSIEMENS HEALTHCARE DIAGNOSTICS INC.
Registered facilityView this company's 12 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass III
StatusTerminated
ReasonPTH Calibrator packaged with only high calibrator.
ProductADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Quantity595 kits total (5 kits with packaging error)
DistributionNationwide Distribution including MD, PA, and CT.
Initiated2013-08-16
Classified2013-11-06
Terminated2014-02-13
Recall numberZ-0173-2014
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Siemens Healthcare Diagnostics, Inc (Z-0173-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66132/

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