Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems Recalled by Siemens Healthcare Diagnostics Due to The ADVIA Chemistry Systems A1c_3 method may exhibit...
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 directly.
Affected Products
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, IVD ADVIA Chemistry A1c_3 Calibrator Information: For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA Chemistry systems. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.
Quantity: Domestic: 1122 kits; Foreign: 236 kits
Why Was This Recalled?
The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report