The FastPack System Comlete Immunoassay Kit recallZ-1672-2020 · Qualigen Inc · initiated Nov 6, 2019
Terminated
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
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On October 31, 2019, a "Urgent: Product Recall" letter was sent to customer via E-Mail. In addition to informing consignees about the recall the customer notification asked consignees to take the following actions: 1. The firm will provide replacement kits at no cost as soon as they become available. 2. For any kits that have been purchased a refund can be requested in place of replacement kits. 3. As part of the product replacement process, please confirm that any remaining SHBG FastPacks/Kits of Lot Number 1908038-1P have been discarded on the form below. 4. The firm will call to confirm that you have received the letter and provide any additional details you may require. For questions, please contact System Support at [email protected].
Recall details
- Recall number
- Z-1672-2020
- Status
- Terminated
- Initiated by the company
- Nov 6, 2019
- Recalling firm
- Qualigen Inc
- Quantity
- 24 Kits (30 test packs each) 720 tests
- Product code
- CDZ
- FDA submissions
- K182521
- Distribution
- US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
Product description
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Code information (models, lots, serial numbers)
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
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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