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
Reported: January 6, 2021 Initiated: December 8, 2020 #Z-0755-2021
Product 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 for Recall
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 7 units
- Distribution
- US Nationwide distribution.
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 7 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 6, 2021. Severity: Moderate. Recall number: Z-0755-2021.
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