Alinity m System recall: Software Issue
Alinity m System, Part No. 08N53-002
Why was Alinity m System recalled?
There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 distribution 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
- Terminated
- Agency
- FDA (device)