Reported Oct 3, 2018 · Terminated
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of %…
Tosoh Bioscience 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: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
- G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
- Lot codes and dates
- Serial Numbers
14646304149172011488611214616503148562121488760114886212 & 14917201
- Serial Numbers
- Amount recalled
- 8 units
Where it was sold
Why it was recalled
Analyzers were distributed with software which lacks a 510K
This product could cause temporary or reversible health problems — stop using it.
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