The FastPack IP Sex Hormone Binding Globulin Immunoassay — Class III medical device recall Z-0805-2025
Ongoing recall by Qualigen Inc, reported 2025-01-15, distributed in AR, CA, CO, FL, IL, IN, MA, MO…. Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expira
| Recall number | Z-0805-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualigen Inc, Carlsbad, CA, United States |
| Recall initiated | 2024-12-03 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | AR, CA, CO, FL, IL, IN, MA, MO, NC, NY, OH, OK, TN, TX, VA |
| Quantity | 426 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20816467020345 |
| Lot numbers | 2408018-1, 2409015-1, 2409015-2 |
| Model numbers | 25000081 |
| Expiration dates | 2025-06-26, 2025-06-27, 2025-09-05 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0805-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.