Roche Molecular Systems, Inc. cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Brand
Roche Molecular Systems, Inc.
Lot Codes / Batch Numbers
UDI-DI 00875197006773 All in-date lots
Products Sold
UDI-DI 00875197006773 All in-date lots
Roche Molecular Systems, Inc. is recalling cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 68 due to The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu 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 true diagnosis.
Recommended Action
Per FDA guidance
On December 22, 2022, Roche posted the Urgent Medical Device Correction (UMDC) to its website (dialog.roche.com). On December 27, 2022, the firm also sent UMDC letters to affected customers. Consignees were instructed to monitor for negative influenza A results that are inconsistent with clinical presentation and/or other clinical and epidemiological information. Authorized or licensed Influenza NAATs are available for confirmation if clinically indicated for at-risk patients. Additionally, consignees are reminded to review the tests Instructions for Use, specifically the Intended Use Statements and Procedural Limitations sections, which provide guidance on how negative results should be utilized and mutations within the target regions of the tests can impact detection, respectively. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026