FDA-Device2022-07-13Class II
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Radiometer Medical ApS
Hazard
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Bermuda, Canada, Italy, Norway, Austria, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, China, Croatia, Denmark, Iceland, Germany, Spain, Portugal, India, Brunei, Japan, United Kingdom, Ireland, Russia, Hungary, Australia, New Zealand, Tokelau, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong, Mexico, South Korea, Singapore.
Affected count
1489 analyzers
Manufactured in
Akandevej 21, N/A, Bronshoj, N/A, Denmark
Products
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1321-2022Don't want to check this manually?
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