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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88341

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

Open FDA event record

Event summary

Timeline bucket
July 22, 2021
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" Mouse IgG2a Isotype Control APC X39 ASR

Z-2333-2021
Recall number
Z-2333-2021
Initiated
July 22, 2021
Classification
Class II
Status
Terminated
Quantity
23 reagents

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing process error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.

Code information

Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.