FDA Device recall Z-2923-2018
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagno…
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagno… by Tecan Us, citing 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 cort….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2923-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-12 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tecan Us |
| Distribution | GA, IA, LA, MA, MN, OR, PA, SC, UT |
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.
Identifiers
| code_info | In USA RE62119 Lot # LCL129 exp. date: 2017-11-30, RE62119 Lot # LCL133 exp. date: 2019-03-31, and RE62111 Lot # L…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2923-2018%22
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