cobas SARS-CoV-2 & Influenza A/B Qualitative assay for recall
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Why was cobas SARS-CoV-2 & Influenza A/B Qualitative assay for 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00875197006674 All in-date lots
- Product
- cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 18,071 kits (US); 30,085 kits (OUS)
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Recall date
- February 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)