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.

626–650 of 667

  • ModerateFDA (Devices)·Z-1049-2013·2013-04-10

    Siemens Dimension Phosphorus Reagent Cartridge Recalled for Result Interference

    Siemens is recalling Dimension Phosphorus reagent cartridges because they can cause falsely low creatinine results when processed near open wells.

    Product
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1048-2013·2013-04-10

    Siemens Dimension EXL 200 Recalled for System Check Failures

    Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL 200 analyzers worldwide due to increased System Check failures that cause inconvenience but do not impact test results.

    Product
    Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1047-2013·2013-04-10

    Siemens Dimension EXL LM STM Recalled for System Check Failures

    Siemens is recalling 2,207 Dimension EXL LM STM analyzers worldwide due to System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1046-2013·2013-04-10

    Siemens Dimension EXL LM Analyzer Recalled for System Check Failures

    Siemens Healthcare Diagnostics is recalling 2,207 Dimension EXL LM analyzers worldwide due to increased System Check failures that cause inconvenience but do not affect test results.

    Product
    Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0988-2013·2013-04-03

    Siemens Dimension Vista Alkaline Phosphatase Calibrator Recalled for Accuracy Shift

    Siemens Healthcare Diagnostics is recalling 1,985 cartons of Dimension Vista Alkaline Phosphatase Calibrators due to correlation slope bias and accuracy shift.

    Product
    Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2013·2013-03-27

    Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery

    Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.

    Product
    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0933-2013·2013-03-20

    Siemens Total Iron Binding Capacity Reagent Cartridge Recall for Labeling Error

    Siemens is recalling Total Iron Binding Capacity reagent cartridges because the stated analytical sensitivity in the instructions is no longer valid.

    Product
    Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2013·2013-02-06

    Siemens Dimension IRON Calibrator Recalled for Calibration Slope Issues

    Siemens Healthcare Diagnostics is recalling Dimension IRON Calibrators because some lots produced calibration results outside acceptable ranges.

    Product
    Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2013·2013-01-16

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0637-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, biliru
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2013·2013-01-16

    Siemens CLINITEK Atlas Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens is recalling CLINITEK Atlas Positive and Negative Control Strips because leukocyte results may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0640-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Inaccurate Leukocyte Results

    Siemens Healthcare Diagnostics Inc is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0635-2013·2013-01-16

    Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity

    Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0641-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0638-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0665-2013·2013-01-16

    Siemens Emit Tox Serum Calibrators Recalled for Incorrect Expiration Date

    Siemens Healthcare Diagnostics is recalling 1,998 cartons of Emit Tox Serum Calibrators because an incorrect expiration date was assigned to Lot D1.

    Product
    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0639-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling specific lots of Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0506-2013·2012-12-19

    Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.

    Product
    Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0512-2013·2012-12-19

    Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits

    Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test results.

    Product
    Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0510-2013·2012-12-19

    Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.

    Product
    Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0508-2013·2012-12-19

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2013·2012-12-19

    Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 because room temperature changes can alter test results.

    Product
    Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2013·2012-12-19

    Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur DHEAS assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2013·2012-12-19

    Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity

    Siemens Healthcare is recalling ADVIA Centaur Folate assays because room temperature changes can alter test results.

    Product
    Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cell
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2013·2012-12-12

    Siemens IRON Flex Reagent Cartridges Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling IRON Flex reagent cartridges because environmental iron contamination can cause falsely elevated test results.

    Product
    Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of disea
    Category
    Medical Device
    Distribution
    46 states