Siemens Healthcare Diagnostics, Inc.: 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

Is my product affected?

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 bi

• UPC 00630414513072
• UPC 00630414513058

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Total Bilirubin_2 assay kits in both 40 mL and 70 mL sizes due to a potential issue with test accuracy. The bilirubin assays may show falsely elevated results in patients who are taking the medication eltrombopag. A total of 5,666 units were distributed in the United States, with an additional 52,202 units distributed internationally across numerous countries. The recalled kits were manufactured between March 2020 and August 2021, and specific lot numbers are identified in the recall notice.

The recall affects laboratory testing equipment used for in vitro diagnostic purposes to measure bilirubin levels in patient blood samples. The source document does not specify what remedy or corrective action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy Distribution: Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan, Baham Quantity: 5666 US and 52202 OUS 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(

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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