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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64610

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 13, 2013
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

4 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 4

ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.

Z-1119-2013
Recall number
Z-1119-2013
Initiated
March 13, 2013
Classification
Class II
Status
Terminated
Quantity
3871

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Negative bias in patient samples for Vitamin D

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Negative bias in patient samples for Vitamin D

Code information

Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88766009 4/28/2013 88786009 4/28/2013 89198009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90671010 6/2/2013 92212010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92395011 8/12/2013 94660011 8/12/2013 95016011 8/12/2013 95313011 8/12/2013

Distribution pattern

Nationwide Distribution.

device · product 2 of 4

ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.

Z-1120-2013
Recall number
Z-1120-2013
Initiated
March 13, 2013
Classification
Class II
Status
Terminated
Quantity
4133

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Negative bias in patient samples for Vitamin D

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Negative bias in patient samples for Vitamin D

Code information

Ready Pack Lot Number: 134009 Kit Lot Number/Exp. Date: 88767009 4/28/2013 88787009 4/28/2013 Ready Pack Lot Number: 134010 Kit Lot Number/Exp. Date: 90253010 6/2/2013 91934010 6/2/2013 Ready Pack Lot Number: 134011 Kit Lot Number/Exp. Date: 92396011 8/12/2013 93363011 8/12/2013 95088011 8/12/2013

Distribution pattern

Nationwide Distribution.

device · product 3 of 4

ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.

Z-1121-2013
Recall number
Z-1121-2013
Initiated
March 13, 2013
Classification
Class II
Status
Terminated
Quantity
372 pk Cals

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Negative bias in patient samples for Vitamin D

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Negative bias in patient samples for Vitamin D

Code information

Lot Number: C3410 Kit Lot Number/Exp. Date: 95197A10 8/16/2013 95031A10 8/16/2013 94607A10 8/16/2013 94155A10 8/16/2013

Distribution pattern

Nationwide Distribution.

device · product 4 of 4

ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative determination of Vit D.

Z-1122-2013
Recall number
Z-1122-2013
Initiated
March 13, 2013
Classification
Class II
Status
Terminated
Quantity
107 6pk Cals

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Negative bias in patient samples for Vitamin D

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Negative bias in patient samples for Vitamin D

Code information

Lot Number: C3410 Kit Lot Number/Exp. Date: 95010A10 8/16/2013

Distribution pattern

Nationwide Distribution.