Chromsystems Instruments & Chemicals GmbH recalls 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used…

Recall date

October 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0521-2021

FDA classification

Class II

Brand / firm

Chromsystems Instruments & Chemicals GmbH

Sold / distributed

US Nationwide distribution in the states of NC and NY.

Why it was recalled

Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.