| Class 2 Device Recall FastPack Testosterone Immunoassay | |
Date Initiated by Firm | November 08, 2013 |
Date Posted | December 19, 2013 |
Recall Status1 |
Terminated 3 on September 18, 2014 |
Recall Number | Z-0548-2014 |
Recall Event ID |
66842 |
510(K)Number | K021972 |
Product Classification |
Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
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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. |
Code Information |
Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014 |
Recalling Firm/ Manufacturer |
Qualigen Inc 2042 Corte del Nogal Carlsbad CA 92011-1438
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For Additional Information Contact | 760-918-9165 |
Manufacturer Reason for Recall | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
FDA Determined Cause 2 | Process change control |
Action | Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you
replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used.
Feel free to contact System Support at 760.579.6900 if you have any
questions or require assistance with returning your kits. |
Quantity in Commerce | 18 |
Distribution | US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CDZ
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