cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
Reported: February 15, 2023 Initiated: December 21, 2022 #Z-1105-2023
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 9,948 OUS only
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190. Recalled by Roche Molecular Systems, Inc.. Units affected: 9,948 OUS only.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1105-2023.
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