FDA Device recall Z-0549-2014
FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic part…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic part… 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-0549-2014 |
| 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 Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 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 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014 |
|---|
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-0549-2014%22
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