medical Class II Updated 2020-04-01

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20

Recalled Product

ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice. In vitro Diagnostic for the determination of direct bilirubin.

Hazard / Issue

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ADVIA CH DBIL_2 (20 mL) 492068 (01)00630414513089(10)492068(17)20210728 ADVIA CH DBIL_2 (20 mL) 486501 (01)00630414513089(10)486501(17)20210628 ADVIA CH DBIL_2 (20 mL) 478164 (01)00630414513089(10)478164(17)20210328 ADVIA CH DBIL_2 (20 mL) 472667 (01)00630414513089(10)472667(17)20210228 ADVIA CH DBIL_2 (20 mL) 469068 (01)00630414513089(10)469068(17)20201228 ADVIA CH DBIL_2 (20 mL) 462448 (01)00630414513089(10)462448(17)20201028 ADVIA CH DBIL_2 (20 mL) 455476 (01)00630414513089(10)455476(17)20200728 ADVIA CH DBIL_2 (20 mL) 452841 (01)00630414513089(10)452841(17)20200628 ADVIA CH DBIL_2 (20 mL) 447337 (01)00630414513089(10)447337(17)20200528 ADVIA CH DBIL_2 (20 mL) 436518 (01)00630414513089(10)436518(17)20200228 ADVIA CH DBIL_2 (70 mL) 486509 (01)00630414513065(10)486509(17)20210628 ADVIA CH DBIL_2 (70 mL) 478169 (01)00630414513065(10)478169(17)20210328 ADVIA CH DBIL_2 (70 mL) 472672 (01)00630414513065(10)472672(17)20210228 ADVIA CH DBIL_2 (70 mL) 469073 (01)00630414513065(10)469073(17)20201228 ADVIA CH DBIL_2 (70 mL) 462453 (01)00630414513065(10)462453(17)20201028 ADVIA CH DBIL_2 (70 mL) 462459 (01)00630414513065(10)462459(17)20201028 ADVIA CH DBIL_2 (70 mL) 455481 (01)00630414513065(10)455481(17)20200728 ADVIA CH DBIL_2 (70 mL) 452846 (01)00630414513065(10)452846(17)20200628 ADVIA CH DBIL_2 (70 mL) 447351 (01)00630414513065(10)447351(17)20200528 ADVIA CH DBIL_2 (70 mL) 447357 (01)00630414513065(10)447357(17)20200528 ADVIA CH DBIL_2 (70 mL) 458975 (01)00630414513065(10)458975(17)20200528 ADVIA CH DBIL_2 (70 mL) 436523 (01)00630414513065(10)436523(17)20200228
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