Date Initiated by Firm |
July 07, 2017 |
Create Date |
September 07, 2017 |
Recall Status1 |
Terminated 3 on October 22, 2018 |
Recall Number |
Z-3112-2017 |
Recall Event ID |
77726 |
510(K)Number |
K123983
|
Product Classification |
System, test, vitamin d - Product Code MRG
|
Product |
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068
Vitamin D immunoassay kit |
Code Information |
Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P |
Recalling Firm/ Manufacturer |
Qualigen Inc 2042 Corte Del Nogal Carlsbad CA 92011-1438
|
For Additional Information Contact |
760-918-9165
|
Manufacturer Reason for Recall |
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm, Qualigen, sent an "URGENT: PRODUCT RECALL" letter dated 7/5/2017 to its customers by email or fax on 07/07/2017. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the products immediately; discard any product remaining in your inventory; and complete, sign and return the attached CONFORMATION OF NOTIFICATION form by email to: babugan@qualigeninc.com or nsomera@qualigenic.com or fax to: 760-918-9127 by 7/15/2017.
Please contact System Support at 877-709-2169, Option #2 if you need further assistance. |
Quantity in Commerce |
493 units |
Distribution |
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = MRG and Original Applicant = Qualigen, Inc.
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