FDASeptember 11, 2019device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to low Quality Control recovery and invalid Calibration.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
05795419190
Recall history
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