Roche cobas e 411 Analyzer Recall for Questionable Results
Roche Diagnostics is recalling cobas e 411 Immunoassay Analyzers because using 13 mm sample tubes without adapters may cause questionable results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that could cause temporary or medically reversible health consequences. The specific hazard is questionable results due to improper tube usage, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Roche Diagnostics Corporation is recalling cobas e 411 Immunoassay Analyzers (Discrete Photometric Analyzer for Clinical use) with catalog numbers 04775201001, 04775279001, 04775201973, and 04775279973. The recall covers both rack and disk system configurations.
The recall was initiated after complaints were received regarding questionable results on the analyzers. These issues occurred when customers utilized 13 mm sample tubes without the required tube adapters.
The affected products were distributed nationwide in the United States. Clinical laboratories and other users of these devices should stop using the affected analyzers and contact Roche Diagnostics for further instructions on the recall.
The recalled product
- Product
- cobas e 411 Immunoassay Analyzer (Discrete Photometric Analyzer for Clinical use), Catalog Numbers: 04775201001 (rack system), 04775279001 (disk system), 04775201973 (rack system) & 04775279973 (disk system).
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
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 (1)
- None
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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