FDA-Device2024-03-20Class II
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Siemens Healthcare Diagnostics, Inc.
Hazard
Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
Sold states
Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of South Korea, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, U.A.E., United Kingdom.
Affected count
264 units (6 US, 258 OUS)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1281-2024Don't want to check this manually?
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