Recall Z-0828-2022

Reason for recall

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

A Customer Bulletin dated 11/16/21 was sent to customers. Analyzer Return Procedure Our records indicate that you have one of the affected cobas Liat analyzers listed on the previous page. Because of the issue, Roche will send you a new cobas Liat analyzer. Please return your affected analyzer immediately to Roche for investigation by following the steps below: 1. A representative from the Roche Support Network Customer Support Center will contact you to initiate analyzer replacement and confirm shipping information. 2. When you receive the new cobas Liat analyzer from Roche, remove the new analyzer and FedEx shipping label from the box. 3. Place the affected analyzer in the box and seal it using packing tape. 4. Affix the FedEx postage paid shipping label to the outside of the box. 5. Take the box containing the affected analyzer to an appropriate FedEx location for return shipping at no charge to you. Actions Required " Follow the steps in the Analyzer Return Procedure section above. " File this Customer Bulletin for future reference. Please contact the Roche Support Network Customer Support Center at 1-800-800-5973 if you have questions about the information in this Customer Bulletin.