The Recall Desk

FDA (Devices) recall action 87488

Siemens Healthcare Diagnostics, Inc. recalled 20 products on 2021-04-21

The FDA (Devices) publishes a recall like this one as 20 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 20 pages.

Products
20
Announced
2021-04-21
Critical
0
Units
4,817

Why these products were recalled

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–20 of 20

  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling ADVIA 2120 Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens is recalling 33 ADVIA 2120i automated hematology analyzers because a potential sample identification mismatch may occur with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120 automated hematology analyzers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch Risk

    Siemens is recalling 1,452 ADVIA 2120i Dual Aspirate Autosamplers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens is recalling 32 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 187 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 7 ADVIA 2120 automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens is recalling 43 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare is recalling 674 ADVIA 2120i Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 185 ADVIA 2120i Dual Aspirate Autosamplers due to potential sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 132 ADVIA 2120 hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.

    Product
    ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 195 ADVIA 2120 automated hematology analyzers worldwide due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch

    Siemens Healthcare Diagnostics is recalling 8 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch

    Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch with 14-character barcodes.

    Product
    ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-04-21

    Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch

    Siemens Healthcare Diagnostics is recalling 969 ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

    Product
    ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
    Category
    Distribution
    0 states