FDA Medical Device Recalls (openFDA)
Qualigen Inc: 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
- Recall number
- Z-1672-2020
- Recalling firm
- Qualigen Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2019-11-06
- Posted
- not on file
- Terminated
- 2020-09-23
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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 systemsupport@qualigeninc.com.
- Quantity
- 24 Kits (30 test packs each) 720 tests
- Distribution
- US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
- Lot, serial or model codes
- 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
- 510(k) numbers
- ["K182521"]
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28