Roche Diagnostics Operations, Inc. Recall 90657
Description: cobas e801 Immunoassay Analyzer
Roche Diagnostics Operations, Inc. Recall 90657 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1515-2022 |
| Event ID | 90657 |
| Event Description | cobas e801 Immunoassay Analyzer |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, DC & PR. |
| Quantity | 965 units |
| Recall Reason | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. |
| Device Classification | 20220817 |
| Device Code Info | UDI-DI: 07613336158456 and 04015630946198; Catalog No. 08454345001 and 07682913001. All serial numbers. |
| Center Classification Date | 20220811 |
| Recall Initiation Date | 20220714 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
| Similar To |