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Abbott Molecular, Inc. Recall 89757

Description: Alinity m HBV Application Specification File (US and CE)

Abbott Molecular, Inc. Recall 89757 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0883-2022
Event ID89757
Event DescriptionAlinity m HBV Application Specification File (US and CE)
Product TypeDevices
DistributionUS consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
Recall ReasonThere is a potential for misquantitation high results of negative samples.
Device Classification20220413
Device Code InfoList Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00
Center Classification Date20220406
Recall Initiation Date20220304
Recalling FirmAbbott Molecular, Inc.
Initial Notification Letter
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