FDA-Device2020-12-09Class II
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Chromsystems Instruments & Chemicals GmbH
Hazard
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Sold states
US Nationwide distribution in the states of NC and NY.
Affected count
850 vials
Manufactured in
Am Haag 12, N/A, Grafelfing, N/A, Germany
Products
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2021Don't want to check this manually?
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