CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report

BD Trucount Controls, 30 Test recalled by Becton, Dickinson and

Becton, Dickinson and Company, BD Bio Sciences is recalling BD Trucount Controls, 30 Test, distributed nationwide in the US. The recall was initiated on 8 Jul 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 4285713/UDI: 00382906643438

Quantity recalled10 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2237-2025
FDA event ID: 97141
Recalling firm: Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jul 2025
FDA classified: 1 Aug 2025
Reported: 13 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Other Medical Devices

Timeline

8 Jul 2025	Recall initiated by company
1 Aug 2025	Classified by FDA	+24 days
13 Aug 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Massachusetts New York Tennessee

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot: 4285713/UDI: 00382906643438

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97141

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025	CLASS II	BD Trucount Controls, 30 Test recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Bio Sciences	Processing Deviation	Nationwide

More recalls from Becton, Dickinson and Company, BD Bio Sciences

All 10

Reported	Class	Recall	Company	Reason	Where
13 Aug 2025Device	CLASS II	BD Trucount Controls, 30 Test recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Bio Sciences	Processing Deviation	Nationwide
9 Jul 2025Device	CLASS II	REF: 335775 , BD Facs, 7-Color Setup Beads, 25 setups per kit, Rx recalled	Becton, Dickinson and Company, BD Bio Sciences	Other	37 states
9 Jul 2025Device	CLASS II	REF: 666289 , BD Facs, 7-Color Setup Beads, 25 Runs, CE recalled	Becton, Dickinson and Company, BD Bio Sciences	Other	37 states
1 Jan 2025Device	CLASS II	Device Description: FACSLyric 2L6C Instrument US recalled	Becton, Dickinson and Company, BD Bio Sciences	Device Malfunction	Nationwide
1 Jan 2025Device	CLASS II	FACSLyric 3L8C Instrument Us-ivd recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Bio Sciences	Device Malfunction	Nationwide

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