FDAClass IISeptember 13, 2017

Qualigen(R) The FastPack(R) IP Vitamin D Complete recall

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

Why was Qualigen(R) The FastPack(R) IP Vitamin D Complete recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Recalling firm
Qualigen Inc
Quantity
493 units
Distribution
Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
Recall date
September 13, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls