Recall Register

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Qualigen Inc

FDA recalling firm · 5 enforcement events · 8 product records · 2013–2024 · CA

Qualigen Inc has 5 FDA enforcement events on this register (8 product records) between 2013 and 2024: 5 device; the busiest year was 2024 with 2.

0% of its events are Class I; the most common class is Class II (4). 2 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
3 Dec 2024The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.DeviceClass III1Ongoing
26 Aug 2024FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System AnalyzerDeviceClass II1Ongoing
6 Nov 2019The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in…DeviceClass II1Terminated
7 Jul 2017Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kitDeviceClass II1Terminated
8 Nov 2013FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate…DeviceClass II4Terminated

By type and class

Device5
Class II4
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Qualigen Inc by year initiated.

Questions and answers

How many FDA recalls has Qualigen Inc had?

5 enforcement events (8 product records) on this register, 2013–2024: 5 device.

Are any Qualigen Inc recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Qualigen Inc recalls?

4 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.