FDA recall Z-0522-2021

Chromsystems Instruments & Chemicals GmbH · Class II · device

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 for recall

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

Distribution

US Nationwide distribution in the states of NC and NY.

Key facts

Status
Completed
Initiation date
2020-10-29
Report date
2020-12-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grafelfing, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2021