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Recall Observatory FDA recall evidence

Device product

ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Z-1822-2025

April 15, 2025

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 96693
Status
Ongoing
Classification
Class II
Quantity
1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
Official record key
device-enforcement:Z-1822-2025

Official wording

Reason: 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.

Code information: Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.