FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Bio Sciences: BD Trucount Controls, 30 Test - REF: 340335
- Recall number
- Z-2238-2025
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Product
- BD Trucount Controls, 30 Test - REF: 340335
- Status
- Open, Classified
- Initiated
- 2025-07-08
- Posted
- 2025-08-01
- Terminated
- not on file
- Reason
- 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
- 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
- 629 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.
- Lot, serial or model codes
- Lot: 85708 UDI: 00382903403356 *Distributed outside the US
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3027394506
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28