Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Customers have reported an increased number of false positive SARS-CoV-2 results.

Recommended Action

Per FDA guidance

On August 4, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were instructed to take the following actions: - Immediately discontinue the use of the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat system, lot number 10119Z. - For handling previous positive results generated with the cobas SARS-CoV-2 & Influenza A/B test for use on the cobas Liat system, follow your laboratory s standard operating procedures to investigate the potential for false positive results. Please consult with the physician or clinicians at your facility to determine specific clinical implications for your patients. - Repeat testing can be performed using other cobas SARS-CoV-2 & Influenza A/B lot numbers. - Complete all sections of the enclosed faxback form and fax it to 1-888-312-5960 or email it to Roche4691@stericycle.com. - Discard lot number 10119Z according to your local waste management ordinance. - File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-800-5973 if you have questions about this recall.