ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 recall
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…
Why was ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 recalled?
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
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 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
- Product
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 1901 Us and 37349 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)