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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66132

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 16, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ADVIA 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.

Z-0173-2014
Recall number
Z-0173-2014
Initiated
August 16, 2013
Classification
Class III
Status
Terminated
Quantity
595 kits total (5 kits with packaging error)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
PTH Calibrator packaged with only high calibrator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

PTH Calibrator packaged with only high calibrator.

Code information

Kit Lot: 14136A16 04 Mar 2014

Distribution pattern

Nationwide Distribution including MD, PA, and CT.

Field note

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