FDA Device recall Z-0547-2014
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic p…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic p… 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-0547-2014 |
| 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 Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA 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 | Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013. |
|---|
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-0547-2014%22
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