Roche Diagnostics Operations, Inc. Recall 86981
Description: Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Roche Diagnostics Operations, Inc. Recall 86981 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0755-2021 |
| Event ID | 86981 |
| Event Description | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 7 units |
| Recall 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. |
| Device Classification | 20210106 |
| Device Code Info | Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10 |
| Center Classification Date | 20201230 |
| Recall Initiation Date | 20201208 |
| Recalling Firm | Roche Diagnostics Operations, Inc. |
| Initial Notification | Letter |
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