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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74537

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

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Event summary

Timeline bucket
June 24, 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

BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.

Z-2252-2016
Recall number
Z-2252-2016
Initiated
June 24, 2016
Classification
Class II
Status
Terminated
Quantity
328 US, 516 International

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

Code information

Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)

Distribution pattern

USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile