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Dpc Cirrus

Country not established

Devices
2
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Dpc Cirrus makes

Dpc Cirrus manufactures immunoassay devices, including the IMMULITE 2000 Carcinoembryonic Antigen (CEA) test kit for detecting tumor markers and the IMMULITE 2000 automated immunoassay analyzer for processing blood samples in clinical labs.

The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements and are intended for in vitro diagnostic use.

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

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls3

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

FDA recall records list 3 recalls initiated by Dpc Cirrus, the earliest on 2003-06-13 and the most recent on 2005-04-22. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware. 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.

  • 2005

    • 22 Apr 2005 Z-0994-05 Unclassified (pre-2012) Terminated The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor. Distribution: worldwide Submission number: K970227

  • 2004

    • 29 Oct 2004 Z-0263-05 Unclassified (pre-2012) Terminated Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'. Distribution: The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in…
      Full distribution text The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.
      Submission number: K033234

  • 2003

    • 13 Jun 2003 Z-1138-03 Unclassified (pre-2012) Terminated Version 2.6 software was released however it will not properly handle adjustment slopes. Distribution: Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics.…
      Full distribution text Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.

Frequently asked questions

How many devices does Dpc Cirrus have in the registry?

The registry currently lists 2 devices for Dpc Cirrus. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dpc Cirrus's devices?

Among its 2 most recently registered devices, Dpc Cirrus has devices listed in FDA 510(k) (2 devices).

What risk classes do Dpc Cirrus's devices fall under?

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

Are there FDA recall records for Dpc Cirrus?

FDA recall records list 3 recalls initiated by Dpc Cirrus, the most recent initiated on 2005-04-22. 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 Dpc Cirrus in the registry?

The most recently registered devices listed for Dpc Cirrus include IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT and IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER.

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