medical Class II Updated 2020-04-01

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40

Recalled Product

ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

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 TBIL_2 (40 mL) 492094 (01)00630414513072(10)492094(17)20210828 ADVIA CH TBIL_2 (40 mL) 486525 (01)00630414513072(10)486525(17)20210728 ADVIA CH TBIL_2 (40 mL) 478149 (01)00630414513072(10)478149(17)20210428 ADVIA CH TBIL_2 (40 mL) 472677 (01)00630414513072(10)472677(17)20210328 ADVIA CH TBIL_2 (40 mL) 469083 (01)00630414513072(10)469083(17)20210128 ADVIA CH TBIL_2 (40 mL) 462464 (01)00630414513072(10)462464(17)20201128 ADVIA CH TBIL_2 (40 mL) 455486 (01)00630414513072(10)455486(17)20200828 ADVIA CH TBIL_2 (40 mL) 452851 (01)00630414513072(10)452851(17)20200728 ADVIA CH TBIL_2 (40 mL) 447317 (01)00630414513072(10)447317(17)20200628 ADVIA CH TBIL_2 (40 mL) 436498 (01)00630414513072(10)436498(17)20200328 ADVIA CH TBIL_2 (70 mL) 492102 (01)00630414513058(10)492102(17)20210828 ADVIA CH TBIL_2 (70 mL) 492111 (01)00630414513058(10)492111(17)20210828 ADVIA CH TBIL_2 (70 mL) 486533 (01)00630414513058(10)486533(17)20210728 ADVIA CH TBIL_2 (70 mL) 478154 (01)00630414513058(10)478154(17)20210428 ADVIA CH TBIL_2 (70 mL) 478159 (01)00630414513058(10)478159(17)20210428 ADVIA CH TBIL_2 (70 mL) 493710 (01)00630414513058(10)493710(17)20210428 ADVIA CH TBIL_2 (70 mL) 490263 (01)00630414513058(10)490263(17)20210328 ADVIA CH TBIL_2 (70 mL) 490264 (01)00630414513058(10)490264(17)20210328 ADVIA CH TBIL_2 (70 mL) 469088 (01)00630414513058(10)469088(17)20210128 ADVIA CH TBIL_2 (70 mL) 469094 (01)00630414513058(10)469094(17)20210128 ADVIA CH TBIL_2 (70 mL) 462470 (01)00630414513058(10)462470(17)20201128 ADVIA CH TBIL_2 (70 mL) 462477 (01)00630414513058(10)462477(17)20201128 ADVIA CH TBIL_2 (70 mL) 455496 (01)00630414513058(10)455496(17)20200828 ADVIA CH TBIL_2 (70 mL) 455501 (01)00630414513058(10)455501(17)20200828 ADVIA CH TBIL_2 (70 mL) 452858 (01)00630414513058(10)452858(17)20200728 ADVIA CH TBIL_2 (70 mL) 452863 (01)00630414513058(10)452863(17)20200728 ADVIA CH TBIL_2 (70 mL) 452870 (01)00630414513058(10)452870(17)20200728 ADVIA CH TBIL_2 (70 mL) 447325 (01)00630414513058(10)447325(17)20200628 ADVIA CH TBIL_2 (70 mL) 447332 (01)00630414513058(10)447332(17)20200628 ADVIA CH TBIL_2 (70 mL) 436510 (01)00630414513058(10)436510(17)20200328 ADVIA CH TBIL_2 (70 mL) 436515 (01)00630414513058(10)436515(17)20200328
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