ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Siemens Material Number: 10310376. UDI Number: (01)00630414468198(10)86237A74(17)20250514, (01)00630414468198(10)44207A75(17)20250925. Kit lot numbers: 86237A74, 44207A75.
Products Sold
Siemens Material Number: 10310376. UDI Number: (01)00630414468198(10)86237A74(17)20250514, (01)00630414468198(10)44207A75(17)20250925. Kit lot numbers: 86237A74, 44207A75.
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. due to Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interv. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026