Tecan Recalls Cortisol Saliva Luminescence Immunoassay Kits for Inaccurate Results
Tecan US, Inc. is recalling specific lots of the IBL International Cortisol Saliva Luminescence Immunoassay because the product generates cortisol values 1.3 to 1.8 times higher than the NIST standard.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to inaccurate diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Tecan US, Inc. is recalling the IBL International Cortisol Saliva Luminescence Immunoassay, an in-vitro diagnostic device used to quantitatively determine cortisol levels in human saliva. The device is intended to aid in the diagnosis and treatment of adrenal disorders and is not intended for point-of-care settings.
The recall is due to the product failing to meet specifications for traceability to the National Institute of Standards and Technology (NIST) cortisol standard. Laboratory samples tested with the affected device generated cortisol values that were 1.3 to 1.8 times higher than the NIST cortisol standard.
The recall affects 870 units distributed in the United States and 180 units distributed outside the US. In the US, distribution was limited to Georgia, Iowa, Louisiana, Massachusetts, Minnesota, Oregon, Pennsylvania, South Carolina, and Utah. Affected US lots include RE62119 Lot # LCL129 (exp. 2017-11-30), RE62119 Lot # LCL133 (exp. 2019-03-31), and RE62111 Lot # LCL130 (exp. 2018-03-31). Outside the US, affected lots include Lot 131 and Lot 132. The product was distributed worldwide to Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
Users should stop using the affected lots and contact Tecan US, Inc. for further instructions.
The recalled product
- Product
- 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. Th
- Manufacturer
- Tecan US, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- In USA RE62119 Lot # LCL129 exp. date: 2017-11-30
- RE62119 Lot # LCL133 exp. date: 2019-03-31
- and RE62111 Lot # LCL130 exp. date: 2018-03-31. OUS Lot 131
- Lot 132
Distribution
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