Diamedix Corporation: Medical Device Recall in 2016 - (Recall #: Z-1685-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

Product Classification:

Class II

Date Initiated: October 20, 2014

Date Posted: May 25, 2016

Recall Number: Z-1685-2016

Event ID: 73694

Reason for Recall:

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

Status: Terminated

Product Quantity: 697 kits

Code Information:

Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015

Distribution Pattern:

Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.

Voluntary or Mandated:

Voluntary: Firm initiated