Qualigen — Class II medical device recall Z-3112-2017
Terminated recall by Qualigen Inc, reported 2017-09-13, distributed nationwide. Specific lots have been reported to produce falsely lower than expected results for Vitamin D
| Recall number | Z-3112-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualigen Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-07-07 |
| Classified | 2017-09-07 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2018-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, DE, TR |
| Quantity | 493 units |
| Lot numbers | 1701033-3P, 1701033-4P, 1701033-5P, 1701033-6P |
| Model numbers | 25000068 |
Product
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Reason for recall
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3112-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.