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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Recalled June 4, 2025 · FDA recall Z-1822-2025 · Siemens Healthcare Diagnostics
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. · FDA Class II
Units
1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
Sold at
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.
Description
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.
Product
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →