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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62494

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

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Event summary

Timeline bucket
June 29, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BD Biosciences, Systems & Reagents

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

BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.

Z-2397-2012
Recall number
Z-2397-2012
Initiated
June 29, 2012
Classification
Class II
Status
Terminated
Quantity
96 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

Code information

Catalog number: 335775; Lot number 33412.

Distribution pattern

Worldwide Distribution -- USA (nationwide) including the countries of Australia, Belgium, Canada, Chile, Korea, Mexico, Singapore and Taiwan.