Recall Z-2923-2018— Tecan US, Inc.
Class II · Terminated
Class II FDA medical device recall by Tecan US, Inc., initiated 2018-01-12, terminated 2020-06-02. It names one FDA 510(k) clearance: K150528. 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. The device is not intended for point-of-care settings.. Reason: 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..
- Recalling firm
- Tecan US, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-12
- Terminated
- 2020-06-02
- Firm location
- Morrisville, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.