Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence Recalled by Tecan US, Inc. Due to Product is not meeting specification for traceability to...
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 Tecan US, Inc. directly.
Affected Products
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
Quantity: 870 (USA) 180 (OUS)
Why Was This Recalled?
Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
Where Was This Sold?
This product was distributed to 9 states: GA, IA, LA, MA, MN, OR, PA, SC, UT
About Tecan US, Inc.
Tecan US, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report