Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2923-2018 — 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 inte

U.S. FDA — Device Enforcement · United States · 2018-01-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2923-2018
Date of alert: 2018-01-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Tecan US, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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