# FDA recall Z-2923-2018

> **Tecan US, Inc.** · Class II · device recall initiated 2018-01-12.

## 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.

## Distribution

Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC,  and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.

## Key facts

- **Recall number:** Z-2923-2018
- **Recalling firm:** Tecan US, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-09-05
- **Termination date:** 2020-06-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2923-2018

## Citation

> AI Analytics. FDA recall Z-2923-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2923-2018. Source: US FDA. Licensed CC0.

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