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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97141

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 08, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton, Dickinson and Company, BD Bio Sciences

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

2 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 2

BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Z-2237-2025
Recall number
Z-2237-2025
Initiated
July 08, 2025
Classification
Class II
Status
Ongoing
Quantity
10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Code information

Lot: 4285713/UDI: 00382906643438

Distribution pattern

Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.

device · product 2 of 2

BD Trucount Controls, 30 Test - REF: 340335

Z-2238-2025
Recall number
Z-2238-2025
Initiated
July 08, 2025
Classification
Class II
Status
Ongoing
Quantity
629 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Code information

Lot: 85708 UDI: 00382903403356 *Distributed outside the US

Distribution pattern

Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom.