FDA-Device2019-09-11Class II

cobas c513 Analyzer

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
2 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas c513 Analyzer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2478-2019

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