Tosoh G8 Automated HPLC Analyzer Recalled for Missing 510(k) Software
Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).
- Product
- 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…
- Category
- Medical Device
- Distribution
- Distributed nationwide