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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68892

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2014
Product types
Device
Classifications
Class III
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 Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

Z-2233-2014
Recall number
Z-2233-2014
Initiated
July 18, 2014
Classification
Class III
Status
Terminated
Quantity
85

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label contains the incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

Code information

Catalog number 340916; Lot number BM084L

Distribution pattern

IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium