Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1821-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

Product Classification:

Class II

Date Initiated: April 15, 2025

Date Posted: June 4, 2025

Recall Number: Z-1821-2025

Event ID: 96693

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.

Status: Ongoing

Product Quantity: 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated