BD Kiestra" Isolate Suspension Cuvette Array — Class II medical device recall Z-0484-2026
Ongoing recall by Becton Dickinson & Co., reported 2025-11-19, distributed nationwide. The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly r
| Recall number | Z-0484-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2025-10-23 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, SG, TW |
| Quantity | 29,760 units |
| UPC / GTIN / UDI-DI | 30382902461006 |
| Lot numbers | LM245590, LM245592, LM245593, LM245594, LM245666 |
| Model numbers | 246100 |
Product
BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Reason for recall
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.
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-0484-2026. 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.