Home / Recalls / Biocare Medical, LLC / Z-2360-2018

Z-2360-2018 Class II Terminated

Recalled by Biocare Medical, LLC — Pacheco, CA

Recall Details

Product Type
Devices
Report Date
July 11, 2018
Initiation Date
April 24, 2018
Termination Date
July 14, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
43 units

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

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.

Distribution Pattern

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

Code Information

Lot numbers 011818 and 022818

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