Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
Recalled Product
cobas e801 Immunoassay Analyzer
Hazard / Issue
Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
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