Cortisol Saliva Luminescence Immunoassay The IBL International… — Class II medical device recall Z-2923-2018
Terminated recall by Tecan US, Inc., reported 2018-09-05, distributed in GA, IA, LA, MA, MN, OR, PA, SC…. Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times high
| Recall number | Z-2923-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2018-01-12 |
| Classified | 2018-08-24 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-06-02 |
| Distributed | GA, IA, LA, MA, MN, OR, PA, SC, UT |
| Countries outside the US | AT, BE, CA, CH, DE, DK, FI, FR, IT, JP, NL, NO, PL, RU, ZA |
| Lot numbers | 131, 132, LCL129, LCL130OUS, LCL133, RE62111, RE62119 |
| Expiration dates | 2017-11-30, 2018-03-31, 2019-03-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2923-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.