FDA recall Z-1797-2018

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2016-07-14

Report date

2018-05-16

Termination date

2020-08-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1797-2018