[pending] The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers inclu
Pending LLM rewrite. Source: FDA_DEVICE Z-1665-2025.
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 design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.
The recalled product
- Product
- The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).
- Manufacturer
- Abbott Molecular, 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 (6)
- All Serial Numbers. 08N53-001
- UDI-DI: 00884999047389
- 08N53-002
- UDI-DI: 00884999048034
- 08N53-032
- UDI-DI: 00884999047587
Distribution
Distributed nationwide across the United States.
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