Roche cobas Influenza Test Recall Due to False Negative Results
Roche Molecular Systems is recalling its cobas Influenza A/B & SARS-CoV-2 test because it has reported false negative results for Influenza A, which may delay diagnosis and treatment.
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: This is an FDA Class II device recall with confirmed false negative test results affecting a critical diagnostic function. While no hospitalizations or illnesses have been reported, the false negatives represent a documented risk-of-harm to patients who may receive inaccurate test results, leading to delayed diagnosis and treatment.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on cobas 5800/6800/8800 Systems (Material Number 09446125190). This device is identified by UDI-DI 00875197006827, with all in-date lots included in the recall. The recall affects 9,948 units, primarily distributed outside the United States, though the device has been distributed domestically nationwide and worldwide.
Roche received customer complaints regarding false negative results for Influenza A and late Influenza A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as delays to obtaining a true diagnosis. These issues may impact the accuracy of patient testing and clinical decision-making.
The recalled product
- Product
- cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
- Manufacturer
- Roche Molecular Systems, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative-results
- diagnostic-error
- delayed-diagnosis
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)
- UDI-DI 00875197006827 All in-date lots
Distribution
Distributed nationwide across the United States.
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