cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/880...
FDA Recall #Z-1105-2023 — Class II — December 21, 2022
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.
Recalling Firm
Roche Molecular Systems, Inc. — Branchburg, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9,948 OUS only
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
UDI-DI 00875197006827 All in-date lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated