BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Pending LLM rewrite. Source: FDA_DEVICE Z-0484-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog No.: 246100
- UDI-DI: 30382902461006
- Lot Number: LM245590
- LM245592
- LM245593
- LM245594
- LM245666
Distribution
Distributed nationwide across the United States.
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