Roche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results
Roche Diagnostics is recalling Omni Micro-electrodes for cobas b221 analyzers because they may leak if used beyond their 52-week lifetime, potentially causing erroneous pH and sodium results.
What this means for you
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 that may produce erroneous critical care results (pH and sodium), which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling Omni Micro-electrode/reference electrodes for the cobas b221 analyzer. The affected product is part of the Roche OMNI S1, S2, S4, and S6 systems. The recall covers all serial numbers and includes distribution in the United States nationwide, Puerto Rico, and Guam.
The recall is being issued because the reference electrode may leak if used beyond its guaranteed 52-week in-use lifetime. This leakage can potentially cause erroneous pH and/or sodium results. The manufacturer notes that other ion parameters are not affected by this issue.
Healthcare facilities and users of the cobas b221 analyzer should stop using the affected electrodes and contact Roche Diagnostics for further instructions on replacement or disposal.
The recalled product
- Product
- Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6
- Manufacturer
- Roche Diagnostics Operations, Inc.
- 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)
- all serial numbers
Distribution
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