Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ADVIA Centaur CA 125II Assay Recalled by Siemens Healthcare Diagnostics, Inc Due to Upon dilution, some patient samples may exhibit over-recovery...
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
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Quantity: SMN 10310443 (1-pack/100 tests) - 13257 kits; SMN 10315696 (5-pack/500 tests) - 9930 kits
Why Was This Recalled?
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
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