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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69334

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

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Event summary

Timeline bucket
August 14, 2014
Product types
Device
Classifications
Class II
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

Dimension Vista¿ HbA1c

Z-0127-2015
Recall number
Z-0127-2015
Initiated
August 14, 2014
Classification
Class II
Status
Terminated
Quantity
20043

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample Containers (SSC). Siemens has confirmed that when whole blood samples are run from SSC, HbA1c values may exhibit a percent bias ranging from - 8.2% t

Code information

catalog #K3105A, material #10470481, All in-date lots

Distribution pattern

Worldwide Distribution: US (nationwide) and country of: Canada.