Drug recall
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is…
FDA recall event 80554 · Class II · Tecan US, Inc.
Key facts
| Event ID | 80554 |
|---|---|
| Recall numbers | Z-2923-2018 |
| Recalling firm | Tecan US, Inc. |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jan 12, 2018 |
| Report date | Sep 5, 2018 |
| Termination date | Jun 2, 2020 |
| City | Morrisville |
| State | NC |
| Country | United States |
| FEI number | 1037985 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: