Z-2237-2025Class II

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

Name: Z-2237-2025 BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Creator: Becton, Dickinson and Company, BD Bio Sciences
Published: 2025-07-08
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2025-07-08 / Open, Classified / root cause: labeling and UDI

FDA source

Becton, Dickinson and Company, BD Bio Sciences began a recall of BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD on 2025-07-08. FDA classified it as Class II and gives the reason as "Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2237-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-08
Posted: 2025-08-01
Recalling firm: Becton, Dickinson and Company, BD Biosciences
Product: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On July 8, 2025, BD Biosciences issued a "Urgent: Medical Device Recall Correction" via mail. BD ask consignees to take the following actions: 1. Ensure the contents of this product notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. It is recommended that this notice be posted where these products are stored. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 5. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program.
Quantity in commerce: 10 kits
Distribution: 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.
Product codes and lots: Lot: 4285713/UDI: 00382906643438

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01
Z-2238-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-01

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)