FDA-Device2025-06-04Class II
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Siemens Healthcare Diagnostics, Inc.
Hazard
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
Sold states
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TX, UT, VA, VT, WI, WY and the countries of Austria, Belgium, Croatia, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Vatikan City, Zaire.
Affected count
1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1822-2025Don't want to check this manually?
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