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Abbott Molecular, Inc. Recall 89167

Description: Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc. Recall 89167 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0461-2022
Event ID89167
Event DescriptionAlinity m System, Part No. 08N53-002
Product TypeDevices
DistributionWorldwide 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.
Quantity742 devices
Recall ReasonThere is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.
Device Classification20220112
Device Code InfoAlinity m System, Model 08N53-002, all serial numbers
Center Classification Date20220106
Recall Initiation Date20211206
Recalling FirmAbbott Molecular, Inc.
Initial Notification E-Mail
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