Recall Z-1515-2022 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
cobas e801 Immunoassay Analyzer
| Date | Jul 14, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | The firm distributed an Urgent Medical Device Correction notification via mail by UPS on 07/14/2022. The notice indicates that cobas e801 (Catalog No. 08454345001) and cobas e801 module (Catalog No. 04682913001) are being recalled due to a software issue affecting all analyzers, which may result in impacted signals and sample results of Pre-Wash tests when using Quick Start Mode for the following assays: Anti-HAV 2, Anti-HBc IgM, IGF-1, Myoglobin, Rubella IgG, and Toxo IgG. Customers with affected units are provided workaround instructions to deactivate Quick Start Mode or additional software |
| Quantity | 965 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.