Reported Sep 9, 2015 · Terminated
MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro…
Diagnostic Hybrids Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostic Hybrids Inc · 1055 E State St · Athens, OH · 45701-7911
Is this the product you have?
- MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
- Lot codes and dates
Model Number A027Lot Number 018186(self-affixed
- EDMA Code12 01 02 04 00; Complement Component Bb)
- Amount recalled
- 171
Where it was sold
Why it was recalled
Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
This product could cause temporary or reversible health problems — stop using it.
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