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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74788

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

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Event summary

Timeline bucket
July 18, 2016
Product types
Device
Classifications
Class III
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 Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.

Z-2378-2016
Recall number
Z-2378-2016
Initiated
July 18, 2016
Classification
Class III
Status
Terminated
Quantity
14,089

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.

Code information

Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017.

Distribution pattern

Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA