FDA-Device2021-01-06Class II
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Roche Diagnostics Operations, Inc.
Hazard
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
Sold states
Domestic: IL, FL, GA, WV
Affected count
152 kits and 7 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2021Don't want to check this manually?
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