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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72548

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

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Event summary

Timeline bucket
October 30, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton, Dickinson and Company, BD Biosciences

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 CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.

Z-0334-2016
Recall number
Z-0334-2016
Initiated
October 30, 2015
Classification
Class II
Status
Terminated
Quantity
23 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Three lots of CD64 (MD22) are contaminated with CD4 antibody.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Three lots of CD64 (MD22) are contaminated with CD4 antibody.

Code information

Model 657701; Lot No. 4344945, 5037611, both with expiry date of 31 DEC 2015; and 5063945 with expiry dte of 29 FEB 2016.

Distribution pattern

Distributed in the states of FL, WA, PA, IL, GA, RI, TX, ND, and IA.