Company: Tosoh Bioscience Inc Date of Enforcement Report: 11/19/2018 Class II: PRODUCT Tosoh AIA-900 immunoassay Analyzer Recall Number: Z-0485-2019 REASON A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later)...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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