Recall Z-0754-2021 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Operations, Inc.
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
| Date | Dec 8, 2020 |
| Status | Open, Classified |
| Reason | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags. |
| Root cause | Software design |
| Action | Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the |
| Quantity | 1050 units |
| Distribution | US Nationwide distribution. |
| 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 |