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Terminated

Alinity m System, Part No. 08N53-002

FDA Recall Z-0462-2022 · Posted None

Recalling FirmAbbott Molecular, Inc.
Recall StatusTerminated
Product CodeMZP
Date Initiated2021-12-06
Date Terminated2026-08-14
Product Quantity742 devices

Reason for Recall

There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

Firm Action

On December 06, 2021 Abbott Molecular issued a Product Recall 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 adjusts the amplification detection clamp height 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 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

Official Source

View FDA Recall →

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

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