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Tripath Imaging, Inc.

Also registered as Tripath Imaging

United StatesFDA applicant, unverified

Devices
31
FDA recalls
24

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Tripath Imaging, Inc. makes

TriPath Imaging, Inc. manufactures automated image analysis systems designed for histopathological examination, including models for assessing Ki-67 proliferation index, HER2/NEu protein expression, and general tissue analysis. These systems are intended for use in diagnostic laboratories to support cancer diagnostics and research by digitizing and analyzing stained tissue samples. The devices are configured to provide quantitative results for biomarkers used in oncology.

The company’s image analysis systems fall under FDA Class II medical devices and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The manufacturer operates from the US, adhering to applicable domestic regulatory requirements for diagnostic imaging tools.

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

Catalogue31

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Company details

DUNS number
103318015
Phone
1-800-638-8663

FDA recalls24

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

FDA recall records list 24 recalls initiated by TRIPATH IMAGING, INC., the earliest on 2011-10-06 and the most recent on 2012-03-22. By recorded status: 24 terminated. The reasons filed fall into these groups: mechanical integrity. 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 24 recalls.

  • 2012

    • 22 Mar 2012 Z-1811-2012 Class III Terminated The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Distribution: Worldwide Distribution. Submission number: P970018
    • 22 Mar 2012 Z-1812-2012 Class III Terminated The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Distribution: Worldwide Distribution. Submission number: P970018
    • 22 Mar 2012 Z-1813-2012 Class III Terminated The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Distribution: Worldwide Distribution. Submission number: P970018
    • 22 Mar 2012 Z-1814-2012 Class III Terminated The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Distribution: Worldwide Distribution. Submission number: P970018
    • 22 Mar 2012 Z-1815-2012 Class III Terminated The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes Distribution: Worldwide Distribution. Submission number: P970018

  • 2011

    • 8 Dec 2011 Z-2085-2012 Class II Terminated Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI,…
      Full distribution text Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
      Submission number: P970018
    • 8 Dec 2011 Z-2086-2012 Class II Terminated Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI,…
      Full distribution text Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
      Submission number: P970018
    • 8 Dec 2011 Z-2087-2012 Class II Terminated Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI,…
      Full distribution text Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
      Submission number: P970018
    • 8 Dec 2011 Z-2088-2012 Class II Terminated Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI,…
      Full distribution text Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
      Submission number: P970018
    • 6 Oct 2011 Z-1629-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
Show all 24 recalls

  • 2011

    • 6 Oct 2011 Z-1630-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1631-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1632-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1633-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1634-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1635-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1636-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1637-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1638-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1639-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1640-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1641-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1642-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009
    • 6 Oct 2011 Z-1643-2012 Unclassified (pre-2012) Terminated The cable tie mounts that adhere to the inside of the FocalPoint do not adhere as intended and can therefore become detached. Distribution: Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia,…
      Full distribution text Worldwide Distribution - USA including AZ, CT, IL, IN, FL, MN, NC, OK, OR, and TX and the countries of Australia, Belgium, Brazil, Canada, Japan and Thailand
      Submission number: P970009

Frequently asked questions

How many devices does TRIPATH IMAGING, INC. have in the registry?

The registry currently lists 31 devices for TRIPATH IMAGING, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list TRIPATH IMAGING, INC.'s devices?

Among its 31 most recently registered devices, TRIPATH IMAGING, INC. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do TRIPATH IMAGING, INC.'s devices fall under?

Among its 31 most recently registered devices, the classes recorded for TRIPATH IMAGING, INC.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for TRIPATH IMAGING, INC.?

FDA recall records list 24 recalls initiated by TRIPATH IMAGING, INC., the most recent initiated on 22 Mar 2012. 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 TRIPATH IMAGING, INC. in the registry?

The most recently registered devices listed for TRIPATH IMAGING, INC. include BD Density Reagent 491306, PrepStain® Syringing Pipettes 490517, PrepStain® Settling Chambers 490520 and BD PrepStain 490528.

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