Qualigen Inc: Medical Device Recall in 2017 - (Recall #: Z-3112-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 7, 2017

Date Posted: September 13, 2017

Recall Number: Z-3112-2017

Event ID: 77726

Reason for Recall:

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

Status: Terminated

Product Quantity: 493 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated