FDA-Device2025-06-04Class II
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
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
2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2025Don't want to check this manually?
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