# FDA recall Z-0805-2025

> **Qualigen Inc** · Class III · device recall initiated 2024-12-03.

## 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 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.

## 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.

## Key facts

- **Recall number:** Z-0805-2025
- **Recalling firm:** Qualigen Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-03
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0805-2025

## Citation

> AI Analytics. FDA recall Z-0805-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0805-2025. Source: US FDA. Licensed CC0.

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