Food, drugs, devices › Qualigen Inc
Device recall: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Qualigen Inc (Carlsbad, CA) initiated this device recall on 7 Jul 2017; FDA lists 1 product record under event 77726, classified Class II.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 22 Oct 2018. Initiation: voluntary: firm initiated. Qualigen Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Qualigen Inc, Carlsbad, CA.
Reason for recall
"Specific lots have been reported to produce falsely lower than expected results for Vitamin D"
Distribution
"Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3112-2017 | Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit | 493 units | Class II | Terminated | 13 Sep 2017 |
Context
Other enforcement events for Qualigen Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Dec 2024 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in | Device | Class III | 1 |
| 26 Aug 2024 | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP | Device | Class II | 1 |
| 6 Nov 2019 | The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent i | Device | Class II | 1 |
| 8 Nov 2013 | FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay | Device | Class II | 4 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Specific lots have been reported to produce falsely lower than expected results for Vitamin D"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 22 Oct 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.