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
This recall has been terminated (originally issued April 24, 2018).
- Company
- Biocare Medical, Llc
- Recall Initiated
- April 24, 2018
- Terminated
- July 14, 2020
- Recall Number
- Z-2360-2018
- Quantity
- 43 units
- Firm Location
- Pacheco, CA
- Official Source
- View on FDA website ↗
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
CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Lot / Code Info
Lot numbers 011818 and 022818
Root Cause
Material/Component Contamination
Action Taken
On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.
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