Recall Z-1797-2018— Diagnostic Hybrids, Inc.

Name: FDA recall Z-1797-2018
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Class II · Terminated

Class II FDA medical device recall by Diagnostic Hybrids, Inc., initiated 2016-07-14, terminated 2020-08-28. It names one FDA 510(k) clearance: K981373. 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..

Recalling firm: Diagnostic Hybrids, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Terminated: 2020-08-28
Firm location: Athens, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K981373 — ALKPHASE-B ASSAY KITMetra Biosystems, Inc.·cleared 1998-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.