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.

551–575 of 667

  • HighFDA (Devices)·Z-1927-2014·2014-07-02

    Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination

    Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.

    Product
    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2014·2014-07-02

    Siemens Dimension LOCI Troponin I Calibrator Recalled for Result Shifts

    Siemens is recalling Dimension LOCI Troponin I Calibrators because they may cause a 24% upward shift in test results.

    Product
    Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1733-2014·2014-06-18

    Siemens Vista Air Compressor Recalled for Fire and Shock Hazards

    Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.

    Product
    Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnos
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1658-2014·2014-06-04

    Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.

    Product
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1659-2014·2014-06-04

    Siemens Recalls ADVIA Centaur BRAHMS PCT 100 Test Kits Due to Interference

    Siemens Healthcare Diagnostics is recalling 16,302 ADVIA Centaur BRAHMS PCT 100 test kits because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1656-2014·2014-06-04

    Siemens ADVIA Centaur VitD 100 Test Recalled Due to Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems VitD 100 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1655-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1653-2014·2014-06-04

    Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.

    Product
    ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1657-2014·2014-06-04

    Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference

    Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay results.

    Product
    ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1654-2014·2014-06-04

    Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference

    Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test results.

    Product
    ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2014·2014-05-28

    Siemens Recalls Dimension Vista Cyclosporine Test Kits Due to Under-Recovery

    Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.

    Product
    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2014·2014-05-14

    Siemens ADVIA Centaur Folate Assay Recalled for Potential Out-of-Range Results

    Siemens Healthcare Diagnostics is recalling specific lots of the ADVIA Centaur Folate assay because serum controls may go out of range low and whole blood patient results may shift.

    Product
    Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1545-2014·2014-05-14

    Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status

    Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.

    Product
    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1076-2014·2014-03-05

    Siemens Dimension Vista Enzyme 1 Calibrator Recalled for QC Shifts

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Enzyme 1 Calibrator due to quality control shifts and imprecision during Pseudocholinesterase calibration.

    Product
    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0940-2014·2014-02-19

    Siemens ADVIA Chemistry Systems Recalled for Software Calibration Defect

    Siemens is recalling ADVIA Chemistry Systems models 1200, 1650, 1800, and 2400 because specific software versions allow the systems to automatically run assay calibrations and quality control.

    Product
    Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2014·2014-02-05

    Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error

    Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.

    Product
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to dupli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2014·2014-01-29

    Siemens CentraLink Software Recall for Potential Patient Data Release Error

    Siemens is recalling CentraLink Data Management System software versions 14.0.4, 14.0.5, and 14.0.8 because a disabled patient result may be released without proper review.

    Product
    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 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 CentraLink software consolidates data fro
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0818-2014·2014-01-29

    Siemens Recalls Dimension Vista Cyclosporine Flex Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,586 Dimension Vista Cyclosporine Flex reagent cartridges due to complaints about variability in quality control and patient results.

    Product
    Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2014·2014-01-29

    Siemens ADVIA Chemistry Systems Recalled for Potential Result Misinterpretation

    Siemens is recalling ADVIA 1200 and 1650 chemistry systems because an overflow flag may cause users to misinterpret or edit test results.

    Product
    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2014·2014-01-15

    Siemens HB1C Flex Reagent Cartridges Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling HB1C Flex Reagent Cartridges due to positive bias and frequent 'Above Assay Range' flags.

    Product
    HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative dete
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2014·2014-01-15

    Siemens HbA1c Flex Reagent Cartridge Recall for Positive Bias

    Siemens is recalling HbA1c Flex reagent cartridges due to positive bias and frequent out-of-range flags, which may affect diabetes monitoring.

    Product
    HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) clinical chemistry system is an in vitro diagnostic assay for the quantitative det
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2014·2014-01-01

    Siemens Dimension Chemistry Wash Recalled for Result Shifts

    Siemens is recalling Dimension Chemistry Wash lots that may cause shifts in QC and patient sample results for specific tests.

    Product
    Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2014·2013-12-25

    Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues

    Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.

    Product
    Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management
    Category
    Medical Device
    Distribution
    Distributed nationwide