FDA Device recall Z-0548-2014
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagne…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagne… by Qualigen, citing qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0548-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Qualigen |
| Distribution | AL, CA, IN, KS, KY, MA, NC, NV, NY, OK, SC, TN, TX, UT, VA, WA |
Product
FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
Reason
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Identifiers
| code_info | Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2014%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.