Recall Z-0522-2021— Chromsystems Instruments & Chemicals GmbH

Name: FDA recall Z-0522-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-29

Class II · Completed

Class II FDA medical device recall by Chromsystems Instruments & Chemicals GmbH, initiated 2020-10-29. FDA's recall record names no specific 510(k) clearance for this event. Product: MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.. Reason: Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone..

Recalling firm: Chromsystems Instruments & Chemicals GmbH
Classification: Class II
Status: Completed
Initiated: 2020-10-29
Firm location: Grafelfing, N/A, Germany

Product description

MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.