medical Class II Updated 2022-08-17

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.
View official government recall

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