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Siemens Healthcare Diagnostics, Inc. recall records

130 reported ongoing

135 records in this archive. Latest source date Jul 13, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Atellica IM Erythropoietin (EPO) Assay (100 Test)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bra...

Official source
FDA device enforcement

ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, IA, IL, MI, MN, NC, NE, NV, NY, OH and TX; The countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bra...

Official source
FDA device enforcement

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM,...

Official source
FDA device enforcement

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813

RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hypon...

Class IIReported ongoing

Distribution: Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovin...

Official source
FDA device enforcement

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447

RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hypon...

Class IIReported ongoing

Distribution: Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovin...

Official source
FDA device enforcement

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448

RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hypon...

Class IIReported ongoing

Distribution: Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovin...

Official source
FDA device enforcement

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449

RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hypon...

Class IIReported ongoing

Distribution: Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovin...

Official source
FDA device enforcement

epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413...

Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is ena...

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution.

Official source
FDA device enforcement

RAPIDPOINT 500e Blood Gas System

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias ...

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia ...

Official source
FDA device enforcement

RAPIDPOINT 500 Blood Gas System

There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels with positive bias ...

Class IIReported ongoing

Distribution: Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia ...

Official source
FDA device enforcement

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

Class IIReported ongoing

Distribution: US Nationwide. Global Distribution

Official source
FDA device enforcement

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the quantitative determination of total protein in human urine a...

There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry sys...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, CT, FL, GA, IA, MD, MI, NJ, NM, NY, OH, PA, SD, TX, UT, and VA. Global distribution.

Official source
FDA device enforcement

Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Te...

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL Cholesterol (LDLC), Atelli...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Official source
FDA device enforcement

Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test C...

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atell...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Official source
FDA device enforcement

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test C...

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atelli...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Official source
FDA device enforcement

Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) Test...

Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atell...

Class IIReported ongoing

Distribution: US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam

Official source
FDA device enforcement

epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Class IIReported ongoing

Distribution: US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finlan...

Official source
FDA device enforcement

epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Class IIReported ongoing

Distribution: US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finlan...

Official source
FDA device enforcement

epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1

There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.

Class IIReported ongoing

Distribution: US distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI, MN, MO, NC, ND, NH, NY, OH, OK, SC, SD, and TX OUS distribution to Canada, China, Colombia, Finlan...

Official source
FDA device enforcement

Aptio Automation Storage and Retrieval Module (SRM)

A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the conditions listed below occur within a fe...

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IL, KY, LA, MA, MD, MI, MS, MT, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, & WV. The countries of A...

Official source

Reasons in these listed records

  • Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Inst...
  • Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
  • RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result i...
  • Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results th...

These examples come from this result page and are not a ranking of every recall reason.

Checking Siemens Healthcare Diagnostics, Inc.

Is there a recall on siemens healthcare diagnostics, inc. right now?

This archive contains 135 records, including 130 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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