FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
- Recall number
- Z-1822-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
- Status
- Open, Classified
- Initiated
- 2025-04-15
- Posted
- 2025-05-27
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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. ***Updates: ***On 10/21/25, a second notice was mailed to all affected US customers to inform them that an additional lot was added to the scope of the recall. Kit lots ending in 77 are affected. ***On 5/1/26, a third notice was mailed to all affected US customers to inform them that an additional affected lot was added. Kit lots ending in 78 and 79 are affected.
- Quantity
- 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
- 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, serial or model codes
- Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79
- 510(k) numbers
- ["K013406"]
- PMA numbers
- not on file
- Product code
- JIS
- Firm FEI
- 1219913
- Firm city
- East Walpole
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28