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Recall Observatory FDA recall evidence

Device product

Alinity m System, Part No. 08N53-002

Z-0461-2022

December 06, 2021

Class II

Product summary

Firm
Abbott Molecular, Inc.
Event
Event 89167
Status
Ongoing
Classification
Class II
Quantity
742 devices
Official record key
device-enforcement:Z-0461-2022

Official wording

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

Code information: Alinity m System, Model 08N53-002, all serial numbers

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue