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Immunetech Corporation

United StatesFDA applicant, unverified

Devices
4
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue4

Newest first, rows 1-4 of 4

  • Myallergytest System Ref K020387

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Immunetech Total Ige System Ref K032251

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Modification To Myallergy Test Ref K061979

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • My Allergy Test Ref K021698

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls6

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

  • 2011

    • 4 Nov 2011 Z-0286-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979
    • 4 Nov 2011 Z-0287-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979
    • 4 Nov 2011 Z-0288-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979
    • 4 Nov 2011 Z-0289-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979
    • 4 Nov 2011 Z-0290-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979
    • 4 Nov 2011 Z-0291-2012 Unclassified (pre-2012) Terminated ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. Distribution: Worldwide distribution. Submission numbers: K021698, K061979

Frequently asked questions

How many devices does Immunetech Corporation have in the registry?

The registry currently lists 4 devices for Immunetech Corporation. Devices recorded under merged duplicate company entries are counted once.

Which registries list Immunetech Corporation's devices?

Among its 4 most recently registered devices, Immunetech Corporation has devices listed in FDA 510(k) (4 devices).

What risk classes do Immunetech Corporation's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Immunetech Corporation's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Immunetech Corporation?

FDA recall records list 6 recalls initiated by Immunetech Corporation, the most recent initiated on 4 Nov 2011. 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 Immunetech Corporation in the registry?

The most recently registered devices listed for Immunetech Corporation include MYALLERGYTEST SYSTEM, IMMUNETECH TOTAL IGE SYSTEM, MODIFICATION TO MYALLERGY TEST and MY ALLERGY TEST.

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