Recall Z-1538-2020
Siemens Healthcare Diagnostics, Inc. · initiated February 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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 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.
Codes / lots: 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…
Reason for recall
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1538-2020
- Initiated
- February 13, 2020
- Terminated
- April 23, 2021
- Product code
- JFM – Enzymatic Method, Bilirubin
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1536-2020 Class II | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1537-2020 Class II | Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1539-2020 Class II | ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL).…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1540-2020 Class II | Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1541-2020 Class II | Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |