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U.S. Department of Health and Human Services

Class 2 Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Complete

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 Class 2 Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Completesee related information
Date Initiated by FirmJuly 07, 2017
Create DateSeptember 07, 2017
Recall Status1 Terminated 3 on October 22, 2018
Recall NumberZ-3112-2017
Recall Event ID 77726
510(K)NumberK123983 
Product Classification System, test, vitamin d - Product Code MRG
ProductQualigen(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
FEI Number 3003355251
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
ActionThe 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 Commerce493 units
DistributionWorldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MRG
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