Qualigen Inc recalls The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG i…

Recall date

December 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0805-2025

FDA classification

Class III

Brand / firm

Qualigen Inc

Sold / distributed

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.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.