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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71843

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

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Event summary

Timeline bucket
July 27, 2015
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

ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.

Z-2739-2015
Recall number
Z-2739-2015
Initiated
July 27, 2015
Classification
Class II
Status
Terminated
Quantity
466

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.

Code information

Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17

Distribution pattern

Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.