FDAClass IIJuly 11, 2018

Vulcan Fast Red Chromogen Kit 2 recall

Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers…

Why was Vulcan Fast Red Chromogen Kit 2 recalled?

Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 011818 and 022818

Product
Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers…
Recalling firm
Biocare Medical, LLC
Quantity
43 units
Distribution
CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Recall date
July 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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