Carlsbad, CA, United States
Qualigen Inc recalls
3 recalls recorded since 2018, most recently on 3 December 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 3 December 2024
- Reason
- 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 military/government/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0805-2025
- 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.
Ongoing Class II Medical devices
- Recall started
- 26 August 2024
- Reason
- 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, Switzerland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0022-2025
- FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Terminated Class II Medical devices
- Recall started
- 6 November 2019
- Terminated
- 23 September 2020
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1672-2020
- 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 s
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.