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Terminated

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

FDA Recall Z-2360-2018 · Posted None

Recalling FirmBiocare Medical, LLC
Recall StatusTerminated
Product CodeNJT
Date Initiated2018-04-24
Date Terminated2020-07-14
Product Quantity43 units

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.

Firm Action

On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.

Root Cause

Material/Component Contamination

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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