Pantex
Pantex · Model N/A · UDI-DI 00850039602191
7
510(k) clearances
20
Adverse events
5
Recalls
5
Facilities
Description
AM/PM Salivary Cortisol Enzyme Immunoassay (1)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-01-12 | Tecan US, Inc. | 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 corti |
| 2007-05-15 | Roche Diagnostics Corp. | The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.