Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1538-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 13, 2020

Date Posted: April 1, 2020

Recall Number: Z-1538-2020

Event ID: 85037

Reason for Recall:

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

Status: Terminated

Product Quantity: 1901 Us and 37349 OUS

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated