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Digene Corp.

United StatesFDA applicant, unverified

Devices
9
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls5

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

  • 2004

    • 28 May 2004 Z-1039-04 Unclassified (pre-2012) Terminated In vitro diagnostic test kit may produce false negative clinical results. Distribution: Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.

  • 2003

    • 7 Feb 2003 Z-0654-03 Unclassified (pre-2012) Terminated In Vitro diagnostic test kit may produce false positive patient results Distribution: Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain.…
      Full distribution text Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
      Submission number: P890064S006
    • 7 Feb 2003 Z-0655-03 Unclassified (pre-2012) Terminated In Vitro diagnostic test kit may produce false positive patient results Distribution: Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain.…
      Full distribution text Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
      Submission number: P890064S006
    • 7 Feb 2003 Z-0656-03 Unclassified (pre-2012) Terminated In Vitro diagnostic test kit may produce false positive patient results Distribution: Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain.…
      Full distribution text Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
      Submission number: P890064S007
    • 7 Feb 2003 Z-0657-03 Unclassified (pre-2012) Terminated In Vitro diagnostic test kit may produce false positive patient results Distribution: Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain.…
      Full distribution text Domestic product was sold to distributors and end users nationwide and to foreign consignees in Barbados and Spain. Product labeled for export only was distributed to Belgium, Brazil, France, Italy, Portugal, Russia, Slovenia, Spain, Switzerland, Germany and the UK. Firm estimates that 40% of distributed product may remain in user channels.
      Submission number: K990023

Frequently asked questions

How many devices does Digene Corp. have in the registry?

The registry currently lists 9 devices for Digene Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Digene Corp.'s devices?

Among its 9 most recently registered devices, Digene Corp. has devices listed in FDA 510(k) (9 devices).

What risk classes do Digene Corp.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Digene Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Digene Corp.?

FDA recall records list 5 recalls initiated by Digene Corp., the most recent initiated on 2004-05-28. 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 Digene Corp. in the registry?

The most recently registered devices listed for Digene Corp. include HYBRID CAPTURE SYSTEM CMV DNA ASSAY, HYBRID CAPTURE II GC-ID, DIGENE DML 2000 MICROPLATE LUMINOMETER and MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01.

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