Z-0521-2021 Class II
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- October 29, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 package units
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.
Distribution Pattern
US Nationwide distribution in the states of NC and NY.
Code Information
Order No. 73039, Lot 3219 (expiration 08/01/2021) and Lot 1020 (Expiration 03/01/2022)