cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- December 21, 2022
- Posted
- February 7, 2023
- Recall Number
- Z-1104-2023
- Quantity
- 18,071 kits (US); 30,085 kits (OUS)
- Firm Location
- Branchburg, NJ
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.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Info
UDI-DI 00875197006674 All in-date lots
Root Cause
Device Design
Action Taken
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