cobas LiatSystem recall
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Why was cobas LiatSystem recalled?
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
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: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
- Product
- cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Recalling firm
- Roche Molecular Systems, Inc.
- Quantity
- 14 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.
- Recall date
- April 6, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)