Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect medical diagnosis) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Qualigen Inc is recalling specific lots of the Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068. The recall involves 493 units distributed nationwide in the US and in Germany, Switzerland, Turkey, and the UAE. The affected lot numbers are 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P.
The recall was initiated because these specific lots have been reported to produce falsely lower than expected results for Vitamin D. This inaccuracy could lead to incorrect clinical interpretations of patient Vitamin D levels.
Healthcare facilities and laboratories should stop using the affected lots and contact Qualigen Inc for instructions on returning the product. Consumers should not use these kits for personal testing.
The recalled product
- Product
- Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- Manufacturer
- Qualigen Inc
- Hazard
- Affected units
- 493
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 (4)
- Lot numbers: 1701033-3P
- 1701033-4P
- 1701033-5P
- and 1701033-6P
Distribution
Distributed nationwide across the United States.
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
- ModerateQualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results
FDA (Devices) · 2020-04-15
- 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
- HighQualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- ModerateQualigen Recalls FastPack Testosterone Immunoassay Kits Due to Manufacturing Defect
FDA (Devices) · 2013-12-25
- ModerateQualigen FastPack SHBG Immunoassay Kit Recalled for Inaccurate Results
FDA (Devices) · 2020-04-15
- HighQualigen Recalls FastPack Total PSA 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
- HighFastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode
FDA (Devices) · 2024-10-16