Z-1821-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 4, 2025
- Initiation Date
- April 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS
Product Description
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Reason for Recall
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.
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.
Code Information
Siemens Material Number: 10995498. UDI Number: (01)00630414598253(10)86236A74(17)20250514, (01)00630414598253(10)44206A75(17)20250925. Kit lot numbers: 86236A74, 44206A75.