FDA Device recall Z-3112-2017
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit by Qualigen, citing specific lots have been reported to produce falsely lower than expected results for Vitamin D.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3112-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-07 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Qualigen |
| Distribution | US |
Product
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Reason
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Identifiers
| code_info | Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3112-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.