FDA-Device2021-01-06Class II
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
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
1050 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2021Don't want to check this manually?
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