Qualigen Inc: Medical Device Recall in 2025 - (Recall #: Z-0805-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: December 3, 2024

Date Posted: January 15, 2025

Recall Number: Z-0805-2025

Event ID: 95807

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 426

Code Information:

UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated