Z-3112-2017Class II

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

Name: Z-3112-2017 Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D...
Creator: Qualigen Inc
Published: 2017-07-07
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2017-07-07 / Terminated

FDA source

Qualigen Inc began a recall of Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit on 2017-07-07. FDA classified it as Class II and gives the reason as "Specific lots have been reported to produce falsely lower than expected results for Vitamin D". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3112-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-07
Posted: 2017-09-07
Terminated: 2018-10-22
Recalling firm: Qualigen Inc
Product: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Product code: MRG System, Test, Vitamin D
Reason for recall: Specific lots have been reported to produce falsely lower than expected results for Vitamin D
FDA root cause: 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: [email protected] or [email protected] 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.
Product codes and lots: Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3112-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3112-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-07

Product code MRG

K123983Class IIFastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc. / cleared 2013-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)