Roche Diagnostics Operations, Inc.: Medical Device Recalls in 2020

According to to data from the FDA, there were 10 medical device recalls made by Roche Diagnostics Operations, Inc. in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

• cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
• Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
• Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
• DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
• BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
• cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
• Tina-quant Complement C4 ver.2, Catalog 05991994190
• Albumin Gen.2, Catalog 05166861190
• Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
• Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.