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Open, Classified

Alinity m System, Part No. 08N53-002

FDA Recall Z-0461-2022 · Posted None

Recalling FirmAbbott Molecular, Inc.
Recall StatusOpen, Classified
Product CodeMZP
Date Initiated2021-12-06
Product Quantity742 devices

Reason for Recall

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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