Reported Aug 17, 2022 · Ongoing
cobas e801 Immunoassay Analyzer
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas e801 Immunoassay Analyzer
- Lot codes and dates
- UDI-DI07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers
- Amount recalled
- 965 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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