Qualigen Inc: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Agency Publication Date: December 19, 2013

Affected Products

Product: 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.

Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

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Product: 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.

Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

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Product: 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.

Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014

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Product: 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

Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66842

Status: Resolved

Manufacturer: Qualigen Inc

Manufactured In: United States

Units Affected: 4 products (182; 18; 17; 6)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

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Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

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Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014

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Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014

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