Recall Z-0675-2018 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
| Date | Jul 28, 2017 |
| Status | Terminated |
| Reason | A software failure may incorrectly set the system settings to "default" settings, creating a risk of incorrect results. |
| Root cause | Device Design |
| Action | Consignees were notified by letter (receipt required) and requested to follow instructions to determine if the software issue has occurred. If the software issue is detected the consignee contacts customer support to have system reconfigured. |
| Quantity | 399 |
| Distribution | Distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER Roche Diagnostics Corp., Sep 9, 2010 |