Siemens Atellica Homocysteine Calibrator Recall: Inaccurate Test Results Risk
Siemens recalls Atellica IM Homocysteine Calibrator (2 Pack) due to unstable calibrators causing inaccurate test results. Affected lots may give false high readings. Contact Siemens for details.
Lower-risk 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.
Contact the company
What happened, in plain English
Siemens is recalling Atellica IM Homocysteine Calibrator (2 Pack) because certain lots are unstable and produce inaccurate test results. This could lead to false high readings in homocysteine tests, potentially affecting medical decisions. Read more at govinfonow.com/recall/52452-siemens-atellica-homocysteine-calibrator-recall-inaccurate-test-results-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52452-siemens-atellica-homocysteine-calibrator-recall-inaccurate-test-results-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1821-2025
Cite this page
“Siemens Atellica Homocysteine Calibrator Recall: Inaccurate Test Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52452-siemens-atellica-homocysteine-calibrator-recall-inaccurate-test-results-risk. Based on FDA recall #Z-1821-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1821-2025%22&limit=1).
Why it’s dangerous
The calibrator may become unstable over time, causing test results to be higher than they should be. This increased positive bias could lead to false high homocysteine readings, which might affect medical decisions if not corrected.
Who’s affected
Lab users who purchased the Atellica IM Homocysteine Calibrator (2 Pack) with Siemens Material Number 10995498 are affected. Those using the calibrator for homocysteine testing in medical labs are most at risk.
How to tell if you have this one
Check for Siemens Material Number 10995498 on the calibrator packaging. Look for lot numbers 86236A74, 44206A75, 25675A77, 44505A78, or 52364A79. The recall was updated on May 8, 2026.
- Brand
Siemens Healthcare- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1821-2025 | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498; Siemens Material Number: 10995498. UDI-DI: 00630414598253 Kit lot numbers: 86236A74, 44206A75. ***Updated 5/8/26*** Additional Lots 25675A77, 44505A78, 52364A79. | 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS |
| Z-1822-2025 | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.; Siemens Material Number: 10310376. UDI-DI 00630414468198 Kit lot numbers: 86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79 | 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS |
What to do — step by step
Check Calibrator Lot Number
Look for lot numbers 86236A74, 44206A75, 25675A77, 44505A78, or 52364A79 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 37 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Vermont, Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1821-2025 (April 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1821-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.