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Abbott Molecular, Inc. recalls Alinity m HBV AMP Kit (US and CE)
Recalled April 13, 2022 · FDA recall Z-0884-2022 · Abbott Molecular
Hazard
There is a potential for misquantitation high results for negative samples. · FDA Class II
Units
4966 kits, updated 101/17/2023
Sold at
US 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
Description
There is a potential for misquantitation high results for negative samples.
Product
Alinity m HBV AMP Kit (US and CE)
Manufacturer(s)
Abbott Molecular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →