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.

501–525 of 667

  • HighFDA (Devices)·Z-1256-2015·2015-03-18

    Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk

    Siemens Healthcare is recalling capillary caps for RAPIDLyte blood collection devices because they may not attach properly, causing glass capillaries to break.

    Product
    Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2015·2015-03-18

    Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk

    Siemens Healthcare is recalling capillary caps that may fail to attach, causing glass capillaries to break.

    Product
    Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311054 Legacy Part number: 478605
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2015·2015-03-18

    Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk

    Siemens Healthcare is recalling capillary caps that may fail to attach, causing glass capillaries to break.

    Product
    Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2015·2015-03-18

    Siemens RapidLab 1245 System Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 241 RapidLab 1245 systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. 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 parameters: RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1255-2015·2015-03-18

    Siemens RAPIDLab 1265 System Recalled for Neonatal Bilirubin Variability

    Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. 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 parameters: RA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2015·2015-03-18

    Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. 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 hemoglo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1252-2015·2015-03-18

    Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability

    Siemens is recalling 3,420 RAPIDPoint 405 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.

    Product
    RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results

    Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias

    Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.

    Product
    ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2015·2015-01-21

    Siemens ADVIA Chemistry XPT Software Recall for Result Overwrite Risk

    Siemens is recalling 7 ADVIA Chemistry XPT systems in Washington due to a software defect that may cause critical results to be overwritten.

    Product
    ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLin
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0946-2015·2015-01-14

    Siemens Recalls Dimension Vista Myoglobin Calibrator Due to Positive Result Shift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Myoglobin Calibrators because they may cause test results to shift up to 12% higher than expected.

    Product
    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2015·2014-12-31

    Siemens ADVIA Centaur Laboratory Analyzer Recall for Tubing Crack Risk

    Siemens is recalling ADVIA Centaur laboratory analyzers because a slight crack in the tubing at the reservoir connector may occur due to mechanical stress.

    Product
    ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2015·2014-12-31

    Siemens ADVIA Centaur XP Immunoassay System Recalled for Tubing Crack Risk

    Siemens Healthcare Diagnostics is recalling 10,515 ADVIA Centaur XP Immunoassay Systems because a slight crack may occur in the tubing at the reservoir connector assembly due to mechanical stress.

    Product
    ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2015·2014-12-31

    Siemens Dimension Vista Lab Systems Recalled for Reagent Performance Issues

    Siemens Healthcare Diagnostics is recalling Dimension Vista 500 and 1500 systems due to reagent probe performance decline that may affect patient and QC results.

    Product
    Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analyte
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0801-2015·2014-12-24

    Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.

    Product
    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0420-2015·2014-12-03

    Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias

    Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.

    Product
    Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2015·2014-11-26

    Siemens ADVIA Centaur Cleaning Solution Recalled for Stability Concerns

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cleaning Solution because its stability is not assured. The product is used in in vitro diagnostic systems.

    Product
    ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use with the ADVIA¿ Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur¿ and ADVIA Ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0229-2015·2014-11-26

    Siemens Recalls ADVIA Centaur BNP Assay Reagents Due to Labeling Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP Assay reagents because approximately 2,000 ReadyPacks contain an incorrect human-readable side label.

    Product
    ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0171-2015·2014-11-19

    Siemens MicroScan Rapid Urine Combo Panel Recalled for False Positive Results

    Siemens Healthcare Diagnostics is recalling Rapid Neg Urine Combo Panel Type 1 due to an increase in false positive susceptible results when used with MicroScan Microbiology Systems.

    Product
    Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultativel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2015·2014-11-19

    Siemens MicroScan Rapid Neg BP Combo Panel Type 3 Recalled for False Positives

    Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.

    Product
    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0212-2015·2014-11-19

    Siemens IMMULITE Calcitonin Control Module Recalled for Typographical Error

    Siemens Healthcare Diagnostics is recalling the IMMULITE Calcitonin Control Module due to a typographical error in the expiration date on the instructions for use.

    Product
    IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0164-2015·2014-11-12

    Siemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays

    Siemens Healthcare Diagnostics is recalling Calibrator E kits due to positive bias in Cortisol and Progesterone assays on ADVIA Centaur Systems.

    Product
    Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0130-2015·2014-11-05

    Siemens Recalls ADVIA Centaur Ferritin Calibrator C Due to Realignment Issue

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator C kits due to a realignment issue with Ferritin Analytical Sensitivity. The recall affects 234 kits distributed worldwide.

    Product
    ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide