[pending] DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytomete
Pending LLM rewrite. Source: FDA_DEVICE Z-0541-2026.
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
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
The recalled product
- Product
- DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
- Manufacturer
- Beckman Coulter Inc.
- 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 (20)
- Catalog Number: C78500 UDI-DI code: 15099590754013 Serial Numbers: BH44060
- BJ09004
- BJ14015
- BJ09010
- BJ13012
- BJ14014
- BJ13011
- BJ14017
- BJ13013
- BJ09003
- BJ09008
- BJ09009
- BH39057
- BH44059
- BJ14016
- BJ05002
- BJ17020
- BJ17021
- BH26031
- BJ19024
Distribution
Distributed nationwide across the United States.
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