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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

251

Past Year

16

Class I (Serious)

2

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 251 recalls

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 1121953...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, a...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, au...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide

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• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i with Single Aspirate Autosampler (SMN 1048892...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN ...

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

FDAMar 5, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: BCS XP System: Multipurpose system for in vitro coagulati...

Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

FDAMar 2, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Enzyme linked immunosorbent assay, for herpes simplex vir...

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.

FDAFeb 8, 2021AL, CA, FL +7 more• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc.: Dimension Vista HDLC - colorimetric method, lipoproteins ...

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.

FDAFeb 3, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - In vitro diagnostic testing of...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product ...

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.

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Produ...

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.

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - Product Usage: automated, imm...

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

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - Product Usage: automated, imm...

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

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro ...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Systems Fructosamine (FRUC)-For in vitro diag...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics Inc: Siemens epoc BGEM Test Card-In vitro diagnostic device fo...

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

FDAAug 28, 2020Nationwide• Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex ...

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

FDAAug 25, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog N...

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.

FDAAug 25, 2020Nationwide• Siemens Healthcare Diagnostics, Inc