FDA-Device2020-12-09Class II
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.
Chromsystems Instruments & Chemicals GmbH
Hazard
Calibrator 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
148 package units
Manufactured in
Am Haag 12, N/A, Grafelfing, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0521-2021Don't want to check this manually?
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