Device product
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Z-1797-2018
Product summary
- Event
- Event 79621
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1004
- Official record key
device-enforcement:Z-1797-2018
Official wording
Reason: There is a possibility of low volume and/or leaking standard bottles.
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.
Derived failure modes
-
Unknown
There is a possibility of low volume and/or leaking standard bottles.