Biocare Medical, LLC: Medical Device Recall in 2018 - (Recall #: Z-2360-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 24, 2018

Date Posted: July 11, 2018

Recall Number: Z-2360-2018

Event ID: 80322

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.

Status: Terminated

Product Quantity: 43 units

Code Information:

Lot numbers 011818 and 022818

Distribution Pattern:

CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany

Voluntary or Mandated:

Voluntary: Firm initiated