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Recall Observatory FDA recall evidence

Device product

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

Z-1797-2018

July 14, 2016

Class II

Product summary

Firm
Diagnostic Hybrids, Inc.
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

    reason.no_named_rule · v1.0.0

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