Z-2360-2018 Class II Terminated
FDA device recall Z-2360-2018 was initiated by Biocare Medical, LLC on April 24, 2018 and is designated Class II. Reason for recall: Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. The recall status is terminated (terminated July 14, 2020). Affected quantity: 43 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- July 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 units
Product Description
Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
Reason for Recall
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Distribution Pattern
CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Code Information
Lot numbers 011818 and 022818