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).
Reported: April 30, 2025 Initiated: March 20, 2025 #Z-1665-2025
Product Description
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).
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Molecular, Inc.
- Units Affected
- N/A
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Des Plaines, IL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Abbott Molecular, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1665-2025.
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