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U.S. Department of Health and Human Services

Class 2 Device Recall VULCAN FAST RED CHROMOGEN KIT 2

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  Class 2 Device Recall VULCAN FAST RED CHROMOGEN KIT 2 see related information
Date Initiated by Firm April 24, 2018
Create Date July 05, 2018
Recall Status1 Terminated 3 on July 14, 2020
Recall Number Z-2360-2018
Recall Event ID 80322
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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
Code Information Lot numbers 011818 and 022818
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
60 Berry Dr
Pacheco CA 94553-5601
For Additional Information Contact
925-603-8002
Manufacturer 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.
FDA Determined
Cause 2		 Material/Component Contamination
Action On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.
Quantity in Commerce 43 units
Distribution CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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