Qualigen Inc: Medical Device Recall in 2024 - (Recall #: Z-0022-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer

Product Classification:

Class II

Date Initiated: August 26, 2024

Date Posted: October 16, 2024

Recall Number: Z-0022-2025

Event ID: 95326

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 60

Code Information:

UDI-DI: 00816467020099, Lot: 2405017-1, Expiration: 2025-05-15

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated