The Alinity m System is designed to automate the steps recall
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…
Why was The Alinity m System is designed to automate the steps 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Serial Numbers. 08N53-001, UDI-DI: 00884999047389; 08N53-002, UDI-DI: 00884999048034; 08N53-032, UDI-DI: 00884999047587
- 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…
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- N/A
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- April 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)