Alinity m System recall: Software Issue
Alinity m System, Part No. 08N53-002
Why was Alinity m System recalled?
There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
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?
Alinity m System, Model 08N53-002, all serial numbers
- Product
- Alinity m System, Part No. 08N53-002
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 742 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam.
- Recall date
- January 12, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)