Home / Recalls / Medical Devices
Roche Diagnostics Operations, Inc. recalls Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determina
Recalled October 23, 2019 · FDA recall Z-0153-2020 · Roche Diagnostics Operations
Hazard
Due to low Quality Control recovery and invalid Calibration. · FDA Class III
Units
2,304 units
Sold at
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.
Description
Due to low Quality Control recovery and invalid Calibration.
Product
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →