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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1536-2020 - 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 dete...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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Z-1537-2020 - 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 quantitati...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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Z-1541-2020 - 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 d...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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Z-1539-2020 - 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...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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Z-1540-2020 - 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 sy...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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Z-1538-2020 - 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 i...
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2
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03/20/2020
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Siemens Healthcare Diagnostics, Inc.
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