Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
- Recall Initiated
- April 15, 2025
- Posted
- May 27, 2025
- Recall Number
- Z-1821-2025
- Quantity
- 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS
- Firm Location
- East Walpole, MA
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
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.
Lot / Code Info
Siemens Material Number: 10995498. UDI Number: (01)00630414598253(10)86236A74(17)20250514, (01)00630414598253(10)44206A75(17)20250925. Kit lot numbers: 86236A74, 44206A75.
Root Cause
Under Investigation by firm
Action Taken
An Urgent Medical Device Correction (UMDC) was mailed to all US affected customers by FedEx, and an Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers on about 04/15/2025. Customers were instructed to review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, discontinue use of and discard the affected devices, and complete and return the Effectiveness Check questionnaire. Customers were also instructed to forward the letter to those who may have received the affected devices.