The Recall Desk

Manufacturer

Siemens Healthcare Diagnostics, Inc.

667 recalls in our database name Siemens Healthcare Diagnostics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
667
Critical
5
Severe
12
Most recent
2026-08-26

Of the 667 recalls from Siemens Healthcare Diagnostics, Inc. we have scored against our rubric, 5 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (2%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

576–600 of 667

  • HighFDA (Devices)·Z-0541-2014·2013-12-25

    Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.

    Product
    Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0433-2014·2013-12-11

    Siemens syngo Lab Data Manager Software Recall for Auto-verification Failures

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager software versions VA11B and VA12A because the system may release results that require manual review or delay result transmission.

    Product
    syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0430-2014·2013-12-11

    Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error

    Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.

    Product
    Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2014·2013-11-13

    Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.

    Product
    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0173-2014·2013-11-13

    Siemens ADVIA Centaur Intact PTH Calibrator Recalled for Packaging Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.

    Product
    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0104-2014·2013-11-06

    Siemens Blood Gas Analyzers Recalled for Patient Identification Error Risk

    Siemens is recalling RAPIDPoint and RAPIDLab blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0106-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1245 blood gas analyzers because users may enter wrong patient IDs, potentially leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1265 blood gas analyzers because users may enter wrong patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab 1200 Series blood gas analyzers because users may enter the wrong patient ID, leading to sample misidentification.

    Product
    Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2014·2013-11-06

    Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0107-2014·2013-11-06

    Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk

    Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.

    Product
    Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0103-2014·2013-11-06

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk

    Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.

    Product
    Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2014·2013-10-23

    Siemens Recalls Dimension Vista Urinary Protein Reagent Cartridges

    Siemens is recalling Dimension Vista Urinary/Cerebrospinal Fluid Protein reagent cartridges due to confirmed absorbance errors during calibration.

    Product
    Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2125-2013·2013-09-18

    Siemens Microscan plus Negative Urine Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Urine Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2123-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 5 Recall

    Siemens is recalling Microscan Synergies Plus Negative Urine Combo 5 panels due to confirmed false susceptibility results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2124-2013·2013-09-18

    Siemens Microscan Plus Negative Combo 3 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Combo 3 panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-nega
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2126-2013·2013-09-18

    Siemens Microscan Plus Negative Breakpoint Combo 4 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan plus Negative Breakpoint Combo 4 panels due to confirmed false susceptible and intermediate misreads for specific antibiotics.

    Product
    Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2120-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Combo 2 Recall for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Combo 2 panels due to confirmed false susceptible and intermediate misreads for Imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2013·2013-09-18

    Siemens Microscan Synergies Plus Negative Urine Combo 1 Recalled for Misreads

    Siemens Healthcare Diagnostics is recalling Microscan Synergies Plus Negative Urine Combo 1 panels due to confirmed false susceptible and intermediate results for imipenem and meropenum.

    Product
    Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2171-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.

    Product
    ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2129-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptibility and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2013·2013-09-18

    Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2172-2013·2013-09-18

    Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling 44 units of ADVIA Centaur Folate reagent due to calibration failures and significant negative shifts in quality control and patient results.

    Product
    ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
    Category
    Medical Device
    Distribution
    46 states