Home / Brands / Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics Recalls
692 recalls on record · July 4, 2012 to August 12, 2026 · Medical Devices
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Ver
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.1
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Ver
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.1
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyz
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
April 21, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 a
Hazard: Potential Sample Identification (SID) Mismatch with14-Character Barcodes
March 24, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
Hazard: Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency (Interval) Failures on the ADVIA Centaur XP System and ADVIA Centaur XPT System.
March 17, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disor
Hazard: Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to discolored reagent observed in some wells 5 and 6 of Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridges lot 20062BA.
January 20, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11
Hazard: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
January 20, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11
Hazard: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
January 20, 2021Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 110
Hazard: Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results
December 30, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative deter
Hazard: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
December 30, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determin
Hazard: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.
November 25, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic test
Hazard: Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
November 25, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic test
Hazard: Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
October 28, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitati
Hazard: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
October 28, 2020Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc recalls Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599151(10)98034139(17)
Hazard: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.