Recall Z-0103-2021

Reason for recall

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

FDA-determined cause: Under Investigation by firm

Action taken

On August 27, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that this was an expansion of the previous notification sent on September 11, 2019, as new products and lots had been added to the scope of the recall. Customers were asked to do the following: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section of the letter for product replacement information. " Complete all sections of the enclosed fax back form and fax or email it according to the instructions on the form even if you are not requesting product replacement. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " File this UMDC for future reference. Roche will replace any of the recalled product remaining in your inventory. To receive replacement product, please complete the response form enclosed with the firm's mailing and fax or email it according to the instructions on the form. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about this recall.