Z-0522-2021 Class II
FDA device recall Z-0522-2021 was initiated by Chromsystems Instruments & Chemicals GmbH on October 29, 2020 and is designated Class II. Reason for recall: Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. Affected quantity: 880 vials.
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
- 880 vials
Product Description
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
Reason for Recall
Control 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. 0349, Lot No. 3219 (Expiration 08/01/2021) and Lot No. 1020 (Expiration 03/01/2022)