Recall Z-2498-2021 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Roche Molecular Systems, Inc.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
| Date | Aug 4, 2021 |
| Status | Terminated |
| Reason | Customers have reported an increased number of false positive SARS-CoV-2 results. |
| Root cause | Under Investigation by firm |
| Action | 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 t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.