BD Trucount recallZ-2237-2025 · Becton, Dickinson and Company, BD Bio Sciences · initiated Jul 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton, Dickinson and Company, BD Bio Sciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-2237-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2025
- Posted by the FDA
- Aug 1, 2025
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Quantity
- 10 kits
- Product code
- GKZ
- 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 description
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Code information (models, lots, serial numbers)
Lot: 4285713/UDI: 00382906643438
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Trucount™ 664343Becton, Dickinson And Company · Counter, differential cell1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97141).
- Z-2238-2025 · Open, ClassifiedBD Trucount Controls, 30 Test - REF: 340335
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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