FDADecember 17, 2018device
Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
057953971900579541919005795320160057953381600579534616005795648190
Recall history
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