BD Trucount Controls — Class II medical device recall Z-2237-2025
Ongoing recall by Becton, Dickinson and Company, BD Bio Sciences, reported 2025-08-13, distributed nationwide. Control kits contain incorrect standard deviation (SD) values for the low and high control beads which comprom
| Recall number | Z-2237-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA, United States |
| Recall initiated | 2025-07-08 |
| Classified | 2025-08-01 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BE, BR, CA, DE, FR, GB, LT, PE, PH |
| Quantity | 10 kits |
| UPC / GTIN / UDI-DI | 00382906643438 |
| Lot numbers | 4285713 |
| Model numbers | 664343 |
Product
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2237-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.