Reported Sep 5, 2018 · Terminated
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for…
Tecan US, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tecan US, Inc. · 9401 Globe Center Dr Ste 140 · Morrisville, NC · 27560-6211
Is this the product you have?
- 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.
- Lot codes and dates
- In USA RE62119 Lot # LCL129 exp
- date
2017-11-30RE62119 Lot # LCL133 exp
- date
2019-03-31and RE62111 Lot # LCL130 exp
- date
2018-03-31. OUS Lot 131Lot 132
- Amount recalled
- 870 (USA) 180 (OUS)
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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