Recall Z-2644-2024

Reason for recall

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

FDA-determined cause: Unknown/Undetermined by firm

Action taken

On July 5, 2024, Ventana Medical Systems, Inc. a subsidiary of Roche Diagnostics issued a "Urgent Medical Device Correction" via UPS to affected consignees. Ventana asked consignees to take the following actions: 1. Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. 2. Please consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. 3. Review all positive results generated with the affected lots. Follow your standard laboratory operating procedures to investigate any suspected false positive results generated with the affected lots. 4. If you performed your initial validation using an affected lot, you should revalidate. 5. Refer to the Product Replacement or Credit section on page three of this UMDC. To receive replacement product OR credit for the unexpired product currently in your inventory, use the following link to access the form: https://go.roche.com/TP-02194. 6. Complete all sections of the enclosed Recall Response form (TP-02195); fax or email it according to the instructions on the form even if you are not requesting replacement product or credit. " Share this notification with all device users within your facility and network to ensure they are aware of this recall. This recall notice should also be shared with any organization where the potentially affected devices have been transferred. " File this Urgent Medical Device Correction (UMDC) for future reference.