Recall Z-0548-2014— Qualigen Inc
Class II · Terminated
Class II FDA medical device recall by Qualigen Inc, initiated 2013-11-08, terminated 2014-09-18. It names one FDA 510(k) clearance: K021972. 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..
- Recalling firm
- Qualigen Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-08
- Terminated
- 2014-09-18
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
Data sourced from openFDA. This site is unofficial and independent of the FDA.