ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Recall date

April 1, 2020

Classification

Class II

Status

Terminated

Agency

FDA (device)