FDA Enforcement
Class II
Ongoing
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
Recall: Z-0755-2021
·
Reported January 6, 2021
Enforcement
- Recall Number
- Z-0755-2021
- Event ID
- 86981
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 6, 2021
- Initiation Date
- December 8, 2020
- Classification Date
- December 30, 2020
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
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
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.
Code Info
Serial Numbers: 1925-10; 1931-04; 1931-05;1931-07;1937-10; 1938-01; 1942-10
Distribution
US Nationwide distribution.
Quantity
7 units