Roche Diagnostics Operations, Inc. cobas e801 Immunoassay Analyzer Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
cobas e801 Immunoassay Analyzer
Brand
Roche Diagnostics Operations, Inc.
Lot Codes / Batch Numbers
UDI-DI: 07613336158456 and 04015630946198, Catalog No. 08454345001 and 07682913001. All serial numbers.
Products Sold
UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers.
Roche Diagnostics Operations, Inc. is recalling cobas e801 Immunoassay Analyzer due to Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm distributed an Urgent Medical Device Correction notification via mail by UPS on 07/14/2022. The notice indicates that cobas e801 (Catalog No. 08454345001) and cobas e801 module (Catalog No. 04682913001) are being recalled due to a software issue affecting all analyzers, which may result in impacted signals and sample results of Pre-Wash tests when using Quick Start Mode for the following assays: Anti-HAV 2, Anti-HBc IgM, IGF-1, Myoglobin, Rubella IgG, and Toxo IgG. Customers with affected units are provided workaround instructions to deactivate Quick Start Mode or additional software maintenance with Quick Start Mode still activated. The firm states that the issue will be fixed in the next software version release. Customers are asked to return the attached Faxback form. Any questions are to be directed to Roche Customer Service at 1-800-428-2336.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026