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Abbott Molecular, Inc. Recall 89166

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

Abbott Molecular, Inc. Recall 89166 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0460-2022
Event ID89166
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 potential for abnormal (non-sigmoidal) amplification curves.
Device Classification20220112
Device Code InfoModel 08N53-002, all serial numbers
Center Classification Date20220106
Recall Initiation Date20211206
Recalling FirmAbbott Molecular, Inc.
Initial Notification E-Mail
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