Recall Z-2360-2018— Biocare Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Biocare Medical, LLC, initiated 2018-04-24, terminated 2020-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer..
- Recalling firm
- Biocare Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-24
- Terminated
- 2020-07-14
- Firm location
- Pacheco, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.