FDA-Device2019-09-11Class II
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Roche Diagnostics Operations, Inc.
Hazard
Quality issue with high pressure solenoid valves
Sold states
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Affected count
19 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2477-2019Don't want to check this manually?
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