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Abbott Molecular, Inc. Recall 89757

Description: Alinity m HBV AMP Kit (US and CE)

Abbott Molecular, Inc. Recall 89757 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0884-2022
Event ID89757
Event DescriptionAlinity m HBV AMP Kit (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
Quantity4966 kits, updated 101/17/2023
Recall ReasonThere is a potential for misquantitation high results for negative samples.
Device Classification20220413
Device Code InfoList Numbers: 1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add: 381583, 529391, 529687, 530273, 531598; 2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596
Center Classification Date20220406
Recall Initiation Date20220304
Recalling FirmAbbott Molecular, Inc.
Initial Notification Letter
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