The FastPack IP Sex Hormone Binding Globulin Immunoassay… recallZ-0805-2025 · Qualigen Inc · initiated Dec 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Qualigen Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
The recalling firm issued letters dated 11/19/2024 via email to their customers explaining the reason for recall and providing the correct expiration dates for each of the affected lot numbers. The risk to health was provided and instructions given to be completed. The instructions were to cease use of the affected product, dispose of all remaining kits from the affected lot numbers, document the number of kits disposed, complete the acknowledgment form by FAX or email within 5 days.
Recall details
- Recall number
- Z-0805-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 3, 2024
- Posted by the FDA
- Jan 3, 2025
- Recalling firm
- Qualigen Inc
- Quantity
- 426
- Product code
- CDZ
- FDA submissions
- K182521
- 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.
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.
Code information (models, lots, serial numbers)
UDI-DI: 20816467020345, Lot numbers: 2408018-1 Exp: 2025-09-05; 2409015-1, Exp: 2025-06-27; and 2409015-2, Exp: 2025-06-26.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FastPack® IP SHBG FastPack® IP SHBG 30 ImmunoassayQualigen Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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