CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report

Vulcan Fast Red Chromogen Kit recalled by Biocare Medical

Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an, distributed in 12 states. The recall was initiated on 24 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers 011818 and 022818

Quantity recalled43 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2360-2018
FDA event ID: 80322
Recalling firm: Biocare Medical, Pacheco, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2018
FDA classified: 5 Jul 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

24 Apr 2018	Recall initiated by company
5 Jul 2018	Classified by FDA	+72 days
11 Jul 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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

California Florida Georgia Illinois Kansas Kentucky Louisiana Massachusetts Oregon Rhode Island Texas Vermont

Questions about this recall

Why was it recalled?

Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.

Which lots are affected?

Lot numbers 011818 and 022818

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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