PlainRecalls

Qualigen Inc

Compiled from official public sources by the publisher.

8 recalls on record · Latest: Jan 15, 2025

Subscribe to new Qualigen Inc recalls (RSS)

Agency notice ledger

Federal filing book Qualigen Inc LIGHT-BOOK · SINGLE-AGENCY

#1,803 of 14,151 · 8 notices · 0.008% archive

  • BOOK 8 notices
  • RANK #1,803 of 14,151
  • SHARE 0.008% archive
  • AGENCY FDA Devices (8)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 15, 2025
  • PHOTO Ab Sciex

Nearest notice-volume peer: Ab Sciex (0 notice gap)

Qualigen Inc accounts for about 0.008% of the 104,423-notice archive on 8 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Qualigen Inc compares to 14,151 recalling firms

Qualigen Inc ranks 1,803rd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Qualigen Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

8 1803rd of 14151 higher than 12,296 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Qualigen Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Qualigen Inc holds about 0.008% of archive notices alongside 8 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Low Jan 15, 2025

The 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.
FDA Devices Moderate Oct 16, 2024

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
FDA Devices Moderate Apr 15, 2020

The 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 the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32

FDA Devices Moderate Sep 13, 2017

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Devices Moderate Dec 25, 2013

FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack 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

FDA Devices Moderate Dec 25, 2013

FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
FDA Devices Moderate Dec 25, 2013

FastPack 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 cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
FDA Devices Moderate Dec 25, 2013

FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.

Qualigen Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (8 here).

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8 Ambriola Co., Inc., The 8

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8

Frequently Asked Questions

How many federal recall notices name Qualigen Inc? ▼
PlainRecalls indexes 8 distinct federal recall events naming Qualigen Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Qualigen Inc sit among other recalling firms? ▼
Qualigen Inc ranks #1,803 of 14,151 by distinct recall-event count among 14,151 firms in this archive (87th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Qualigen Inc's notices? ▼
FDA Devices accounts for 8 of this firm's 8 indexed notices.
What product category dominates Qualigen Inc's filing book? ▼
Filings for Qualigen Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Qualigen Inc: 8 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Qualigen Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026