Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 Recalled by Siemens Healthcare Diagnostics, Inc. Due to Certain lots of Atellica IM Homocysteine Calibrator and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Healthcare Diagnostics, Inc. directly.
Affected Products
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Quantity: 2,212 packs (4,424 units) - 448 packs US, 1,764 packs OUS
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report