Device 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.
Z-0521-2021
Product summary
- Event
- Event 86699
- Status
- Completed
- Classification
- Class II
- Quantity
- 148 package units
- Official record key
device-enforcement:Z-0521-2021
Official wording
Reason: Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.
Code information: Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)
Distribution pattern: US Nationwide distribution in the states of NC and NY.
Derived failure modes
-
Unknown
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.