FDA Medical Device Recalls (openFDA)
Diagnostic Hybrids, Inc.: MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
- Recall number
- Z-1797-2018
- Recalling firm
- Diagnostic Hybrids, Inc.
- Product
- MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
- Status
- Terminated
- Initiated
- 2016-07-14
- Posted
- not on file
- Terminated
- 2020-08-28
- Reason
- There is a possibility of low volume and/or leaking standard bottles.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 1004
- 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, serial or model codes
- Lot 067850
- 510(k) numbers
- ["K981373"]
- PMA numbers
- not on file
- Product code
- CIN
- Firm FEI
- 1000122536
- Firm city
- Athens
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28