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 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).

Recall number

Z-1539-2020

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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).

Status

Terminated

Initiated

2020-02-13

Posted

not on file

Terminated

2021-04-23

Reason

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

Root cause

Under Investigation by firm

Action

Siemens Healthineers issued Urgent Medical Device Correction (UMDC # ACHC-20-02.A.US, ACHC-20-02.A.US.AC, ACHC-20-02.A.US.DM, ACHC-20-02.A.US.DV) and Urgent Field Safety Notice (UFSN # ACHC-20-02.A.OUS, ACHC-20-02.A.OUS.AC, ACHC-20-02.A.OUS.DM, ACHC-20-02.A.OUS.DV) on February 13, 2020 to all Atellica CH, ADVIA CH, Dimension, and Dimension Vista customers to inform them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to:Review the information on eltrombopag interference (ADVIA CH and Atellica CH bilirubins) or use of total bilirubin assay is not recommended for patients on eltrombopag therapy (Dimension and Dimension Vista). Review the letter with their Medical Director Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. If they have received any complaints of illness or adverse events associated with the product, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative.

Quantity

5666 US and 52202 OUS

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, Bahamas, Bahrain, Bangladesh, Benin, Bosnia Herzegovina, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Ecuador, Egypt, French Guinea, Georgia, Guadeloupe, Hong Kong, India, Indonesia, Iraq, Iran, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macedonia, Malawi, Malaysia, Mali, Mexico, Montenegro, Morocco, Mozambique, Myanmar, New Zealand, Nigeria, Oman, Pakistan, Peru, Philippines, Qatar, Republic if Yemen, Republic Korea, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, Swaziland, Taiwan, Tanzania, Thailand, Tunisia, Turkmenistan, United Arab Emirates, Ukraine, Uruguay, Venezuela, Vietnam, Zimbabwe

Lot, serial or model codes

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

510(k) numbers

["K170065"]

PMA numbers

not on file

Product code

JFM

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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