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

Recalled December 9, 2020 · FDA recall Z-0521-2021 · Chromsystems Instruments & Chemicals

Hazard
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone. · FDA Class II
Units
148 package units
Sold at
US Nationwide distribution in the states of NC and NY.

Description

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

Product
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.
Manufacturer(s)
Chromsystems Instruments & Chemicals GmbH
Made in
Germany

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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