Recall Z-1105-2023— Roche Molecular Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2022-12-21. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190. Reason: 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..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-21
- Firm location
- Branchburg, NJ, United States
Product description
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.