FDA Device recall Z-0484-2026
BD Kiestra" Isolate Suspension Cuvette Array
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of BD Kiestra" Isolate Suspension Cuvette Array by Becton Dickinson And, citing the 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an err….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0484-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-23 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Reason
The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Identifiers
| code_info | Catalog No.: 246100; UDI-DI: 30382902461006; Lot Number: LM245590, LM245592, LM245593, LM245594, LM245666; |
|---|
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-0484-2026%22
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