# FDA recall Z-1797-2018

> **Diagnostic Hybrids, Inc.** · Class II · device recall initiated 2016-07-14.

## 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

- **Recall number:** Z-1797-2018
- **Recalling firm:** Diagnostic Hybrids, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1797-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1797-2018. Source: US FDA. Licensed CC0.

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