Diagnostic Hybrids, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1497-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immune complexes may initiate complement mediated damage of various organs and tissues. This activation of complement may begin a series of potentially destructive events including cell lysis, the production of anaphylatoxins, leukocyte stimulation and activation of macrophages. Major tissue damage can also occur when CIC fix to cell membranes as in some cases of glomerulonephritiscirculating immune complexes (CIC) in human serum or plasma.

Product Classification:

Class III

Date Initiated: November 3, 2015

Date Posted: May 2, 2018

Recall Number: Z-1497-2018

Event ID: 79642

Reason for Recall:

A component of the kit was found to contain bacterial contamination.

Status: Terminated

Product Quantity: 19 kits

Code Information:

Lot 051076

Distribution Pattern:

Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated