The Recall Desk

FDA (Devices) recall action 85037

Siemens Healthcare Diagnostics, Inc. recalled 6 products on 2020-04-01

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-04-01
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • ModerateFDA (Devices)··2020-04-01

    Siemens ADVIA Chemistry Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Total Bilirubin assays because they may show falsely high results for patients taking eltrombopag.

    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 quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry system
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    0 states
  • ModerateFDA (Devices)··2020-04-01

    Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference

    Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high results for patients taking eltrombopag.

    Product
    Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bi
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    0 states
  • ModerateFDA (Devices)··2020-04-01

    Siemens ADVIA Chemistry Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in patients taking eltrombopag.

    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
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    0 states
  • ModerateFDA (Devices)··2020-04-01

    Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate high results for patients taking eltrombopag.

    Product
    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)
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    0 states
  • ModerateFDA (Devices)··2020-04-01

    Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.

    Product
    Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum
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    0 states
  • ModerateFDA (Devices)··2020-04-01

    Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Direct Bilirubin assays because they may show inaccurate results for patients taking eltrombopag.

    Product
    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - 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
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    0 states