Diagnostic Hybrids, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1797-2018)

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 BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Product Classification:

Class II

Date Initiated: July 14, 2016

Date Posted: May 16, 2018

Recall Number: Z-1797-2018

Event ID: 79621

Reason for Recall:

There is a possibility of low volume and/or leaking standard bottles.

Status: Terminated

Product Quantity: 1004

Code Information:

Lot 067850

Distribution Pattern:

The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.

Voluntary or Mandated:

Voluntary: Firm initiated