FDA-Device2019-10-23Class III
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Roche Diagnostics Operations, Inc.
Hazard
Due to low Quality Control recovery and invalid Calibration.
Sold states
US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
Affected count
2,304 units
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2020Don't want to check this manually?
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