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Abbott Molecular, Inc. Recall 89168

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

Abbott Molecular, Inc. Recall 89168 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0462-2022
Event ID89168
Event DescriptionAlinity m System, Part No. 08N53-002
Product TypeDevices
DistributionWorldwide 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
Quantity742 devices
Recall ReasonThere is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.
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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