Z-1821-2025Class II

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

Name: Z-1821-2025 Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-04-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-04-15 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 on 2025-04-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1821-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-15
Posted: 2025-05-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Product code: JIS Calibrator, Primary
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.
Root cause tag: labeling and UDI
FDA 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.
Quantity in commerce: 2,212 packs (4,424 units) - 448 packs US, 1,764 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.
Product codes and lots: Siemens Material Number: 10995498. UDI Number: (01)00630414598253(10)86236A74(17)20250514, (01)00630414598253(10)44206A75(17)20250925. Kit lot numbers: 86236A74, 44206A75.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-27
Z-1822-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-27

Product code JIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)