Diagnostic Hybrids, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1498-2018)

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 SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.

Product Classification:

Class III

Date Initiated: November 3, 2015

Date Posted: May 2, 2018

Recall Number: Z-1498-2018

Event ID: 79642

Reason for Recall:

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

Status: Terminated

Product Quantity: 107 kits

Code Information:

Lot 052418

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