MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
This recall has been terminated (originally issued July 14, 2016).
- Company
- Diagnostic Hybrids, Inc.
- Recall Initiated
- July 14, 2016
- Terminated
- August 28, 2020
- Recall Number
- Z-1797-2018
- Quantity
- 1004
- Firm Location
- Athens, OH
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot 067850
Root Cause
Process control
Action Taken
Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.