Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results
Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as FDA Class II, which indicates significant potential for harm. The software defect affects the accuracy of diagnostic test results for six assays, creating risk of misdiagnosis; however, no illnesses or injuries have been reported, placing it in the High category rather than Severe.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling approximately 965 cobas e801 Immunoassay Analyzers that were distributed nationwide across all U.S. states, territories, and the District of Columbia.
The recall is due to a software defect that impacts Pre-Wash test signals and sample test results. Six diagnostic assays are affected: Anti-HAV2, Anti-HBc IgM, IGF-1, Myoglobin, Rubella IgG, and Toxo IgG. The software issue could result in incorrect or unreliable test results from these assays.
Healthcare facilities and clinical laboratories currently using the affected devices should discontinue use of the impacted assays and contact Roche Diagnostics for instructions on applying the software correction. The FDA has classified this as a Class II recall. No illnesses or injuries have been reported to date.
The recalled product
- Product
- cobas e801 Immunoassay Analyzer
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 965
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 07613336158456 and 04015630946198
- Catalog No. 08454345001 and 07682913001. All serial numbers.
Distribution
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