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Open, Classified

cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190

FDA Recall Z-1106-2023 · Posted 2023-02-07

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusOpen, Classified
Product CodeQLT
Date Initiated2022-12-21
Product Quantity727 kits OUS only

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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