Recall Z-0417-2015— Diagnostic Hybrids Inc
Class II · Terminated
Class II FDA medical device recall by Diagnostic Hybrids Inc, initiated 2014-10-16, terminated 2015-09-03. FDA's recall record names no specific 510(k) clearance for this event. Product: MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.. Reason: Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented..
- Recalling firm
- Diagnostic Hybrids Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-16
- Terminated
- 2015-09-03
- Firm location
- Athens, OH, United States
Product description
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
Reason for recall
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
Data sourced from openFDA. This site is unofficial and independent of the FDA.