FDA-Device2022-04-13Class II
Alinity m HBV AMP Kit (US and CE)
Abbott Molecular, Inc.
Hazard
There is a potential for misquantitation high results for negative samples.
Sold states
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
Affected count
4966 kits, updated 101/17/2023
Manufactured in
1300 E Touhy Ave, Des Plaines, IL, United States
Products
Alinity m HBV AMP Kit (US and CE)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2022Don't want to check this manually?
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