Z-2360-2018Class II

Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline...

Name: Z-2360-2018 Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline...
Creator: Biocare Medical, LLC
Published: 2018-04-24
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2018-04-24 / Terminated / root cause: manufacturing process

FDA source

Biocare Medical, LLC began a recall of Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L... on 2018-04-24. FDA classified it as Class II and gives the reason as "Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2360-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-24
Posted: 2018-07-05
Terminated: 2020-07-14
Recalling firm: Biocare Medical LLC
Product: 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 code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: On April 24, 2018 the recalling firm issued a notification letter to their customers with instructions to return a response form.
Quantity in commerce: 43 units
Distribution: CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Product codes and lots: Lot numbers 011818 and 022818

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2360-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2360-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)