Exact FDA event identifier

Event 71826

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

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Event summary

Timeline bucket: July 17, 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 CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.

Z-2453-2015

Recall number: Z-2453-2015
Initiated: July 17, 2015
Classification: Class II
Status: Terminated
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Quantity: 362 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.

Code information

Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015

Distribution pattern

US Distribution and Internationally to Taiwan.