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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75250

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

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Event summary

Timeline bucket
September 21, 2016
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

CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen

Z-0128-2017
Recall number
Z-0128-2017
Initiated
September 21, 2016
Classification
Class II
Status
Terminated
Quantity
14 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CD79b (SN8) PE is contaminated with a FITC conjugate of unknown antigenic specificity

Code information

Lot number: 5348570; Expiration Date: 31 July 2017

Distribution pattern

Nationwide Distribution to CA, MN, OH and TX.