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Terminated

Alinity m System, Part No. 08N53-002

FDA Recall Z-0463-2022 · Posted None

Recalling FirmAbbott Molecular, Inc.
Recall StatusTerminated
Product CodeMZP
Date Initiated2021-12-06
Date Terminated2024-09-30
Product Quantity74 devices

Reason for Recall

There is an issue with the installation of updated camera firmware on the system.

Firm Action

On December 06, 2021 Abbott Molecular issued a Product Correction letter to all customers who received an Alinity m instrument impacted by this issue (List Number 08N53 002). Customers are being informed of a previously completed assessment conducted by Abbott FSEs. Customers were initially informed at the time of the assessment, but proper reconciliation of the communication was not performed. 100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.

Root Cause

Software design

Distribution Pattern

Distribution in the United States in CA, DC, GA, KY, IL, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI OUS distribution to Australia, Cambodia, Canada, Columbia, France, Germany, Israel, Italy, Malaysia, Mozambique, Portugal, South Africa, Spain, Switzerland, Taiwan, 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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