Roche cobas Flu/COVID assay recalled for false negative influenza results
Roche Molecular Systems recalls cobas SARS-CoV-2 & Influenza A/B assay kits used in clinical laboratories. The kits may produce false negative Influenza A results, potentially delaying accurate diagnosis.
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 Class II diagnostic device produces false negative test results, risking missed or delayed diagnosis and delays to treatment. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Roche Molecular Systems, Inc. has recalled the cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on cobas 6800/8800 laboratory systems. Approximately 18,071 kits were distributed domestically in the United States, and 30,085 kits were distributed internationally.
The recall was initiated due to customer complaints regarding false negative Influenza A test results and delayed Influenza A Target Ct values. False negative test results may lead to additional testing, psychological distress, and delays to appropriate antiviral therapy for influenza, as well as delays to correct diagnosis.
The affected product includes all in-date lots identified by UDI-DI 00875197006674. Healthcare facilities using these assay kits should contact Roche Molecular Systems regarding the recall and any appropriate corrective actions.
The recalled product
- Product
- cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
- Manufacturer
- Roche Molecular Systems, Inc.
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 00875197006674 All in-date lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Molecular Systems, Inc. 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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