Qualigen Inc: Device Recall

Recall #Z-0022-2025 · 08/26/2024

Class II: Risk

Recall Details

Recall Number: Z-0022-2025
Classification: Class II
Product Type: Device
Recalling Firm: Qualigen Inc
Status: Ongoing
Date Initiated: 08/26/2024
Location: Carlsbad, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 60

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.

Product Description

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

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

Other Recalls by Qualigen Inc

Class III: Low Risk 12/03/2024

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.

View all recalls by Qualigen Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.