Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VULCAN FAST RED CHROMOGEN KIT 2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VULCAN FAST RED CHROMOGEN KIT 2see related information
Date Initiated by FirmApril 24, 2018
Create DateJuly 05, 2018
Recall Status1 Terminated 3 on July 14, 2020
Recall NumberZ-2360-2018
Recall Event ID 80322
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
ProductVulcan 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
FEI Number 3004140393
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
ActionOn April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.
Quantity in Commerce43 units
DistributionCA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Total Product Life CycleTPLC 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.
-
-