Recall Z-2238-2025
Becton, Dickinson and Company, BD Bio Sciences · initiated July 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD Trucount Controls, 30 Test - REF: 340335
Codes / lots: Lot: 85708 UDI: 00382903403356 *Distributed outside the US
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.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-2238-2025
- Initiated
- July 8, 2025
- Posted by FDA
- August 1, 2025
- Product code
- GKZ – Counter, Differential Cell
- 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.
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2237-2025 Class II | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDControl kits contain incorrect standard deviation (SD) values for the low and high control beads which… | 07/08/2025Open, Classified |