Roche Molecular Systems, Inc. Recall 88600
Description: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Roche Molecular Systems, Inc. Recall 88600 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2498-2021 |
| Event ID | 88600 |
| Event Description | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 |
| Product Type | Devices |
| 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. |
| Quantity | 211 kits (US); 3073 kits (OUS) |
| Recall Reason | Customers have reported an increased number of false positive SARS-CoV-2 results. |
| Device Classification | 20210929 |
| Device Code Info | Lot 10119Z |
| Center Classification Date | 20210921 |
| Recall Initiation Date | 20210804 |
| Recalling Firm | Roche Molecular Systems, Inc. |
| Similar To |