RecallDepth

Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

Company
Qualigen Inc
Recall Initiated
July 7, 2017
Terminated
October 22, 2018
Recall Number
Z-3112-2017
Quantity
493 units
Firm Location
Carlsbad, CA

Reason for Recall

Specific lots have been reported to produce falsely lower than expected results for Vitamin D

Distribution

Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.

Lot / Code Info

Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P

Root Cause

Under Investigation by firm

Action Taken

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.

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