Roche cobas e 601 Immunoassay Analyzer Recalled for Questionable Results
Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.
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: The recall involves a medical device where the defect (questionable results) poses a risk of harm through diagnostic error, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Roche Diagnostics Corporation is recalling the cobas e 601 module: Immunoassay Analyzer, which is used for clinical chemistry and immunoassay testing. The affected units include specific catalog numbers: 04745922001, 05036348001, 05860652001, 04745922692, and 05036348692. The recall is distributed nationwide in the United States.
The recall was initiated after complaints were received concerning questionable results on the analyzers. The source text indicates that these issues occurred when customers utilized 13 sample tubes without the required tube adapters. This defect may lead to inaccurate clinical test results.
Healthcare facilities and laboratories using these specific analyzer modules should verify if they have the affected catalog numbers. Users should stop using the affected units and contact Roche Diagnostics Corporation for further instructions on replacement or repair. No specific illnesses or injuries are reported in the source text, but the risk involves potential diagnostic errors.
The recalled product
- Product
- c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692
- Manufacturer
- Roche Diagnostics Corporation
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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