---
title: "The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is ... — FDA record Z-0805-2025 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0805-2025-the-fastpack-ip-sex-hormone-binding-globulin-immunoassay-part-25000081-is-for-the-quantitative-measu/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## 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

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0805-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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.

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Indiana](https://isitonrecall.com/state/indiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## 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.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0805-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Qualigen Inc records](https://isitonrecall.com/brand/qualigen-inc/)