FDA-Device2019-10-16Class II
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Roche Diagnostics Operations, Inc.
Hazard
Inaccurately Low Sample Results
Sold states
AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY
Affected count
27676 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0042-2020Don't want to check this manually?
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