FDA Device recall Z-2237-2025
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
- FDA Device
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD by Becton Dickinson And Bd Bio Sciences, citing control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2237-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-08 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Bio Sciences |
| Distribution | US |
Product
BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD
Reason
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Identifiers
| code_info | Lot: 4285713/UDI: 00382906643438 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2237-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.