Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Siemens ADVIA Centaur Systems Calibrator A Kits Recalled by Siemens Healthcare Diagnostics, Inc Due to Siemens Healthcare Diagnostics has confirmed a negative bias...
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
Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Quantity: 194 kits
Why Was This Recalled?
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics, Inc
Siemens Healthcare Diagnostics, Inc has 118 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report