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).
Enforcement
- Recall Number
- Z-1539-2020
- Event ID
- 85037
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2020
- Initiation Date
- February 13, 2020
- Classification Date
- March 20, 2020
- Termination Date
- April 23, 2021
- Address
- 500 Gbc Dr, N/A, Newark, DE, 19702-2466, United States
Description
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).
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
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
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
5666 US and 52202 OUS