Recall Z-0521-2021— Chromsystems Instruments & Chemicals GmbH
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: 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.. Reason: Calibrator 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
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.
Reason for recall
Calibrator 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.