Z-1797-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- July 14, 2016
- Termination Date
- August 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1004
Product Description
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 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.
Code Information
Lot 067850