Z-1105-2023 Class II Ongoing
FDA device recall Z-1105-2023 was initiated by Roche Molecular Systems, Inc. on December 21, 2022 and is designated Class II. 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, psycholo… The recall status is ongoing. Affected quantity: 9,948 OUS only.
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- December 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,948 OUS only
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Code Information
UDI-DI 00875197006827 All in-date lots