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U.S. Department of Health and Human Services

Class 2 Device Recall cobas Influenza A/B & RSV UC Qualitative nucleic acid test for use on the cobas 6800/8800 Systems

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  Class 2 Device Recall cobas Influenza A/B & RSV UC Qualitative nucleic acid test for use on the cobas 6800/8800 Systems see related information
Date Initiated by Firm December 21, 2022
Date Posted February 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-1106-2023
Recall Event ID 91482
Product Classification COVID-19 multi-analyte respiratory panel nucleic acid devices - Product Code QLT
Product cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Code Information UDI-DI 00875197006773 All in-date lots
Recalling Firm/
Manufacturer		 Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg NJ 08876-3733
For Additional Information Contact Roche Support Network Customer Support Center
800-428-2336
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action 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
Quantity in Commerce 727 kits OUS only
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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