FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Alinity m System, Part No. 08N53-002
- Recall number
- Z-0461-2022
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Alinity m System, Part No. 08N53-002
- Status
- Open, Classified
- Initiated
- 2021-12-06
- Posted
- not on file
- Terminated
- not on file
- Reason
- There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
- Root cause
- Software design
- Action
- On December 06, 2021 Abbott Molecular issued an attached Product Correction letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative assesses and/or corrects the board values on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.
- 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.
- Lot, serial or model codes
- Alinity m System, Model 08N53-002, all serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MZP
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28