FDA Device recall Z-1797-2018
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum by Diagnostic Hybrids, citing there is a possibility of low volume and/or leaking standard bottles.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1797-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-14 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostic Hybrids |
| Distribution | CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, WI |
Product
MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Reason
There is a possibility of low volume and/or leaking standard bottles.
Identifiers
| code_info | Lot 067850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1797-2018%22
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