Qualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results
Qualigen Inc is recalling FastPack System Complete Immunoassay Kits for SHBG because they may produce higher than expected results, leading to inaccurate quantitative determinations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to inaccurate test results, which fits the criteria for a moderate severity score.
Plain-English summary
Qualigen Inc is recalling the FastPack System Complete Immunoassay Kit for the Quantitative Measurement of SHBG (Sex Hormone Binding Globulin). The recall involves 24 kits, containing a total of 720 tests, which were distributed nationwide in the states of Alabama, Alaska, California, Hawaii, and Texas.
The recall was initiated because the chemiluminescent immunoassay has been noted to produce higher than expected results. This defect may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma. The assay is intended for use as an aid in the diagnosis of androgen disorders.
Healthcare facilities and laboratories that possess these kits should stop using them and contact Qualigen Inc for instructions on how to return the product. The recall is classified as Class II by the FDA.
The recalled product
- 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…
- Manufacturer
- Qualigen Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
Distribution
Related recalls
Same manufacturer · Qualigen Inc
See all →- ModerateDiagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2025-01-15
- HighFastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode
FDA (Devices) · 2024-10-16
- HighQualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
FDA (Devices) · 2017-09-13
- HighQualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- HighQualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
Same hazard · inaccurate results
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateDiagnostic Immunoassay Kits Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2025-01-15
- ModerateQualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- HighQualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- HighQualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- ModerateQualigen Recalls FastPack Free T4 Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- HighQualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
FDA (Devices) · 2017-09-13