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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71831

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

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Event summary

Timeline bucket
July 23, 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

Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Z-2450-2015
Recall number
Z-2450-2015
Initiated
July 23, 2015
Classification
Class II
Status
Terminated
Quantity
Total 1655 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Environmental control

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Inspect official wording and provenance

Reason for recall

customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.

Code information

Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13; Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26

Distribution pattern

US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI