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Qualigen Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000025168

Qualigen Inc. is a medical device manufacturer based in the United States, with 45 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II, Class I and Unclassified; EU IVD Annex II List B) and 10 FDA recalls as of 14 Nov 2026.

Devices
45
Registrations
EUDAMED
FDA recalls
102 ongoing

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 28
  • FDA 510(k) 15
  • EUDAMED 14

A device listed in two registries counts in both.

Device classes
  • FDA Class II 22
  • FDA Class I 20
  • EU IVD Annex II List B 2
  • FDA Unclassified 1
Top EMDN categories
FDA recalls
Identifiers
  • EUDAMED SRN US-MF-000025168
  • DUNS 959103565

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

What Qualigen Inc. makes

Qualigen Inc. manufactures in vitro diagnostic (IVD) kits and analyzers for chemiluminescent immunoassays. These products include tests for total prostate-specific antigen (tPSA), total testosterone, total human chorionic gonadotropin (hCG), sex hormone binding globulin (SHBG), and 25-hydroxy vitamin D. The company also produces controls and calibrators for these assays.

The company's portfolio is regulated under U.S. federal law, with devices listed in the FDA's 510(k) database and the Unique Device Identification (UDI) registry. Qualigen Inc. is based in the United States.

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

Catalogue45

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Rows 1-45 of 45

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000025168
DUNS number
959103565
EUDAMED status
Active
EUDAMED registered name
Qualigen, Inc.
Registered address
2042, Corte del Nogal, 92011, Carlsbad, United States
Phone
760-918-9165
PRRC contact
Scott Doyle(public in EUDAMED)

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 10 recalls initiated by QUALIGEN INC., the earliest on 2003-09-19 and the most recent on 2024-12-03. By recorded status: 2 ongoing and 8 terminated. The reasons filed fall into these groups: labeling or instructions for use, performance or accuracy and manufacturing or quality process. 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.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 2
  • 2025 0
  • 2026 0

6 initiated before 2017

  • 2024

    • 3 Dec 2024 Z-0805-2025 Class III Ongoing Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age. Distribution: Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no…
      Full distribution text Distribution was made to AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, and VA. There was no military/government/foreign distribution.
      Submission number: K182521
    • 26 Aug 2024 Z-0022-2025 Class II Ongoing Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected. Distribution: US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany,…
      Full distribution text US: TX, MS, NY, OH, MT, WA, PA, MN, SC, GA, NC, NV, WY, AK, SD, KS, NE, VT, AL, MA, OK, UT, WI, IA, WV. OUS: Germany, Switzerland
      Submission number: K052301

  • 2019

    • 6 Nov 2019 Z-1672-2020 Class II Terminated The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. Distribution: US Nationwide distribution in the states of AL, AK, CA, HI, and TX. Submission number: K182521

  • 2017

    • 7 Jul 2017 Z-3112-2017 Class II Terminated Specific lots have been reported to produce falsely lower than expected results for Vitamin D Distribution: Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE. Submission number: K123983

  • 2013

    • 8 Nov 2013 Z-0547-2014 Class II Terminated Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Distribution: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. Submission number: K994419
    • 8 Nov 2013 Z-0548-2014 Class II Terminated Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Distribution: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. Submission number: K021972
    • 8 Nov 2013 Z-0549-2014 Class II Terminated Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Distribution: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. Submission number: K030329
    • 8 Nov 2013 Z-0550-2014 Class II Terminated Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. Distribution: US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. Submission number: K123983

  • 2008

    • 29 Sep 2008 Z-0500-2009 Unclassified (pre-2012) Terminated The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations. Distribution: Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea. Submission number: K994419

  • 2003

    • 19 Sep 2003 Z-0090-04 Unclassified (pre-2012) Terminated Kits may produce results that are falsely elevated. Distribution: Nationwide and Switzerland.

Frequently asked questions

How many devices does QUALIGEN INC. have in the registry?

The registry currently lists 45 devices for QUALIGEN INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list QUALIGEN INC.'s devices?

Among its 45 most recently registered devices, QUALIGEN INC. has devices listed in EUDAMED (14 devices), FDA 510(k) (15 devices) and FDA GUDID (28 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do QUALIGEN INC.'s devices fall under?

Among its 45 most recently registered devices, the classes recorded for QUALIGEN INC.'s devices are Class I, Class II and IVD Annex II List B. Each device page shows its own class and authorisation.

Are there FDA recall records for QUALIGEN INC.?

FDA recall records list 10 recalls initiated by QUALIGEN INC., the most recent initiated on 3 Dec 2024. 2 of them are recorded as ongoing. 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 QUALIGEN INC. in the registry?

The most recently registered devices listed for QUALIGEN INC. include FastPack Total PSA Calibrator 25s Kit, FastPack IP Total PSA Immunoassay, FastPack® IP Total PSA Kit (30) TPSA Immunoassay and FastPack® IP hCG Diluent Kit (25).

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