[pending] BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;
Pending LLM rewrite. Source: FDA_DEVICE Z-0484-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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