FDA Medical devices recall ·
ADVIA Centaur HCY Calibrator (2 Pack) recall
- Recall number
- Z-1822-2025
- Date
- (initiated April 15, 2025)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
333 Coney St, East Walpole, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79
Distribution
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Kentucky Massachusetts Maryland Maine Michigan Missouri Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Texas Utah Virginia Vermont Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1822-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.