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Atellica IM Homocysteine Calibrator (2 Pack). Siemens… recallZ-1821-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1821-2025
Status
Open, Classified
Initiated by the company
Apr 15, 2025
Posted by the FDA
May 27, 2025
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS
Product code
JIS
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 description

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

Code information (models, lots, serial numbers)

Siemens Material Number: 10995498. UDI-DI: 00630414598253 Kit lot numbers: 86236A74, 44206A75. ***Updated 5/8/26*** Additional Lots 25675A77, 44505A78, 52364A79.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 96693).

Sources and updates

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