Z-1821-2025 Class II Ongoing
FDA device recall Z-1821-2025 was initiated by Siemens Healthcare Diagnostics, Inc. on April 15, 2025 and is designated Class II. 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 incr… The recall status is ongoing. Affected quantity: 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS.
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
Reason for Recall
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.