Recall archive / FDA device enforcement
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG... — FDA record Z-0805-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- 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.
- Classification
- Class III
- Recalling firm
- Qualigen Inc
- Quantity
- 426
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0805-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26. |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 15, 2025
- Recall initiation date
- Dec 3, 2024
- Center classification date
- Jan 3, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.