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Dakocytomation California, Inc.

United StatesFDA applicant, unverified

Devices
2
FDA recalls
13

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Dakocytomation California, Inc. makes

Dakocytomation California, Inc. produces immunohistochemical (IHC) testing kits, including the ER/PR PharmDx Kit for hormone receptor analysis in breast cancer tissue, and flow cytometry reagents such as the CYAN DXD Multitest panel for lymphocyte subset identification (CD8, CD4, CD3) and related fluorescent markers.

These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) database. Dakocytomation California, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls13

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 13 recalls initiated by Dakocytomation California, Inc., the earliest on 2005-09-29 and the most recent on 2005-10-14. By recorded status: 13 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 13 recalls.

  • 2005

    • 14 Oct 2005 Z-0310-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0311-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0312--06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0313-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0314-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0315-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0316-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0317-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0318-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 14 Oct 2005 Z-0319-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
Show all 13 recalls

  • 2005

    • 14 Oct 2005 Z-0320-06 Unclassified (pre-2012) Terminated This recall has been initiated due to a formulation error in the EnVision+ visualization reagent. Distribution: Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH,…
      Full distribution text Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
    • 29 Sep 2005 Z-0113-06 Unclassified (pre-2012) Terminated Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation. Distribution: Nationwide Submission number: P980018
    • 29 Sep 2005 Z-0114-06 Unclassified (pre-2012) Terminated Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test kits. The error was in the concentration of Polyethylene Glycol contained in the formulation. Distribution: Nationwide

Frequently asked questions

How many devices does Dakocytomation California, Inc. have in the registry?

The registry currently lists 2 devices for Dakocytomation California, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dakocytomation California, Inc.'s devices?

Among its 2 most recently registered devices, Dakocytomation California, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Dakocytomation California, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Dakocytomation California, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Dakocytomation California, Inc.?

FDA recall records list 13 recalls initiated by Dakocytomation California, Inc., the most recent initiated on 2005-10-14. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Dakocytomation California, Inc. in the registry?

The most recently registered devices listed for Dakocytomation California, Inc. include DAKOCYTOMATION ER/PR PHARMDX KIT and CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES.

Generated automatically from registry data and not verified by a human reviewer.