FDA Devices Moderate Class II Terminated

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Reported: September 29, 2021 Initiated: August 4, 2021 #Z-2498-2021

Product Description

Reason for Recall

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

Details

Recalling Firm: Roche Molecular Systems, Inc.
Units Affected: 211 kits (US); 3073 kits (OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
Location: Branchburg, NJ

Frequently Asked Questions

What product was recalled? ▼

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190. Recalled by Roche Molecular Systems, Inc.. Units affected: 211 kits (US); 3073 kits (OUS).

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2498-2021.