Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended Recalled by Siemens Healthcare Diagnostics, Inc Due to A rare variant of TSH, identified in a...
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
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Quantity: 18584
Why Was This Recalled?
A rare variant of TSH, identified in a small cluster of patients, is not detected.
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