FDA-Device2020-06-24Class II
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Abbott Gmbh & Co. KG
Hazard
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Sold states
U.S. States: AR, CA, CO, FL, GA, KS, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OK, SC, SD, TN, TX, UT, VA, WI, PR Worldwide distribution: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAMAICA, JORDAN, KENYA, MALAYSAI, MEXICO, NEW CALEDONIA, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, SAUDIA ARABIA, SERBIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE, UK, URUGUAY, and VIETNAM.
Affected count
421 serial numbers
Manufactured in
Max-Planck-Ring 2, 65205, Wiesbaden, Germany
Products
Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2020Don't want to check this manually?
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