Diagnostic Hybrids Inc: Medical Device Recall in 2015 - (Recall #: Z-0417-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.

Product Classification:

Class II

Date Initiated: October 16, 2014

Date Posted: September 9, 2015

Recall Number: Z-0417-2015

Event ID: 69545

Reason for Recall:

Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.

Status: Terminated

Product Quantity: 171

Code Information:

Model Number A027; Lot Number 018186; (self-affixed, EDMA Code: 12 01 02 04 00; Complement Component Bb)

Distribution Pattern:

Worldwide Distribution - USA, including AL, CO, CT, FL, KY, MN, NC, NV, OH, PA, and WA; and, the countries of Canada, China, India, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated