ADVIA® 560 Hematology System 11170842Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414601816), received between Feb 2, 2018 and Mar 3, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K112755); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF A FALSE LOW EOSINOPHIL RESULT OBTAINED ON AN ADVIA 560 HEMATOLOGY SYSTEM. THE RESULT WAS APPROPRIATELY FLAGGED AND THE ADVIA 560 HEMATOLOGY SYSTEM OPERATOR'S GUIDE INSTRUCTED THE CUSTOMER TO PERFORM A MANUAL COUNT ON A STAINED SMEAR. THE CUSTOMER PERFORMED THE MANUAL COUNT, AND THE EOSINOPHIL RESULT WAS HIGHER. THE HIGHER EOSINOPHIL RESULT FROM THE MANUAL COUNT WAS CONSIDERED TO BE THE CORRECT RESULT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE LOW EOSINOPHIL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500847 ↗
• MalfunctionOct 27, 2022Failure to Read Input Signal; Failure to Read Input Signal

  THE CUSTOMER REPORTED AN ISSUE ON THEIR ADVIA 560 HEMATOLOGY SYSTEM WHERE THE AUTOLOADER WOULD DUPLICATE THE BARCODE SENT TO THE SYSTEM FROM THE TUBE IN POSITION 7 TO THE TUBE IN POSITION 8 OF THE AUTOSAMPLER RACK. THE RESULTS FROM THE TUBE IN POSITION 8 WOULD THEREFORE BE ASSIGNED TO THE INCORRECT PATIENT. THE REST OF THE TUBES WERE READ WITH THE CORRECT BARCODE. NO PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR THE INCORRECT PATIENT DUE TO THIS ISSUE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685654 ↗
• MalfunctionJun 17, 2022High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB), MEAN CORPUSCULAR HEMOGLOBIN (MCH), AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 560 HEMATOLOGY SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR HGB, MCH, AND MCHC ON THE ADVIA 560 HEMATOLOGY SYSTEM AS WELL AS ON A NON-SIEMENS ANALYZER. THE RESULTS ON THE ADVIA 560 HEMATOLOGY SYSTEM AGAIN RECOVERED FALSELY ELEVATED, AND THE RESULTS OBTAINED ON THE NON-SIEMENS ANALYZER RECOVERED LOWER. THE LOWER RESULTS OBTAINED ON THE NON-SIEMENS ANALYZER WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DUE TO THE ONE DAY DELAY IN OBTAINING THE CORRECT HGB RESULT, THERE WAS A DELAY IN PERFORMING A BLOOD TRANSFUSION FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HGB, MCH, AND MCHC RESULTS, OR DUE TO THE DELAY IN PERFORMING THE BLOOD TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734534 ↗
• MalfunctionJun 17, 2022High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB), MEAN CORPUSCULAR HEMOGLOBIN (MCH), AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 560 HEMATOLOGY SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR FOR HGB, MCH, AND MCHC ON THE ADVIA 560 HEMATOLOGY SYSTEM AS WELL AS ON A NON-SIEMENS ANALYZER. THE RESULTS ON THE ADVIA 560 HEMATOLOGY SYSTEM AGAIN RECOVERED FALSELY ELEVATED, AND THE RESULTS OBTAINED ON THE NON-SIEMENS ANALYZER RECOVERED LOWER. THE LOWER RESULTS OBTAINED ON THE NON-SIEMENS ANALYZER WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DUE TO THE ONE DAY DELAY IN OBTAINING THE CORRECT HGB RESULT, THERE WAS A DELAY IN PERFORMING A BLOOD TRANSFUSION FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HGB, MCH, AND MCHC RESULTS, OR DUE TO THE DELAY IN PERFORMING THE BLOOD TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734513 ↗
• MalfunctionJul 2, 2021Smoking; Smoking

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) OBSERVED SMOKE AS WELL AS A BURNING SMELL FROM THE CUSTOMER'S ADVIA 560 HEMATOLOGY SYSTEM (SERIAL NUMBER: (B)(4)) WHILE REPLACING A SYSTEM DISPLAY COMPONENT DURING SYSTEM TROUBLESHOOTING. THE INSTRUMENT WAS THEN SHUT DOWN. THERE WAS NO DELAY IN TESTING AS THE CUSTOMER HAD A BACKUP SYSTEM TO PROCESS SAMPLES. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108010 ↗
• MalfunctionJun 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 560 HEMATOLOGY SYSTEM. THE PATIENT SAMPLE WAS RUN FOR HGB, AS PART OF A COMPLETE BLOOD COUNT (CBC), FOUR TIMES ON THE AFFECTED ADVIA 560 HEMATOLOGY SYSTEM. HGB RECOVERED FALSELY LOW ALL FOUR TIMES. THE PATIENT WAS REDRAWN AND WAS RUN USING THE SAME SAMPLE ID FOR HGB, AS PART OF A CBC, THREE ADDITIONAL TIMES ON THE AFFECTED ADVIA 560 HEMATOLOGY SYSTEM AND CONTINUED TO RECOVER FALSELY LOW. THE RESULTS OF THE SEVEN CBCS WERE REPORTED TO THE PHYSICIAN(S). DUE TO THE FALSE LOW HGB RESULTS, THE PATIENT RECEIVED A BLOOD TRANSFUSION. THE CUSTOMER SENT THE SAMPLE TO AN ALTERNATE LABORATORY AND THE HGB TEST WAS REPEATED ON AN UNKNOWN SYSTEM, RECOVERING HIGHER. THE ALTERNATE TEST RESULT WAS CONSIDERED TO BE THE CORRECT RESULT AND A CORRECTED REPORT WAS REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT ALLEGE ANY DISCORDANT RESULTS OF THE OTHER CBC PARAMETERS OBTAINED ON THE ADVIA 560 HEMATOLOGY SYSTEM. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS AND THE SUBSEQUENT TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026241 ↗
• MalfunctionMar 5, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW RED BLOOD CELL (RBC) RESULT WAS OBTAINED ON AN ADVIA 560 HEMATOLOGY SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN TWICE FOR RBC, AND BOTH REPEAT RESULTS RECOVERED HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW RBC RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793427 ↗
• MalfunctionDec 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT HEMOGLOBIN (HGB), HEMATOCRIT (HCT), RED BLOOD CELLS (RBC), AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 560 HEMATOLOGY SYSTEM COMPARED TO RESULTS GENERATED ON THE LAB'S ADVIA 2120I HEMATOLOGY SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE HGB, HCT, RBC, AND RDW RESULTS OBTAINED ON THE LAB'S ADVIA 2120I HEMATOLOGY SYSTEM WERE CONSIDERED CORRECT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HEMOGLOBIN (HGB), HEMATOCRIT (HCT), RED BLOOD CELLS (RBC), AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9412092 ↗
• MalfunctionNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SAMPLE BARCODE WAS MISREAD ON AN ADVIA 560 HEMATOLOGY SYSTEM WITH AN AUTOLOADER. PATIENT SAMPLE IDENTIFICATION NUMBER (SID) (B)(6) WAS MISREAD AS SID (B)(6). THERE WAS NO OTHER PATIENT SAMPLE WITH THE SID (B)(6). INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9295311 ↗
• MalfunctionJul 9, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED HEMOGLOBIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 560 HEMATOLOGY SYSTEM (SERIAL NUMBER: (B)(4)). THE SAME SAMPLE WAS REPEATED FOR BOTH TOTAL HEMOGLOBIN AND CELLULAR HEMOGLOBIN USING AN ADVIA 2120I HEMATOLOGY SYSTEM, BOTH RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED HEMOGLOBIN RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8771321 ↗
• MalfunctionMar 22, 2019Device Handling Problem; Device Handling Problem

  A CUSTOMER OBSERVED SMOKE COMING FROM THE RIGHT SIDE OF THE ADVIA 560 HEMATOLOGY SYSTEM. THE SMOKE WAS OBSERVED FROM THE CENTRAL PROCESSING UNIT (CPU) BOARD. THE CUSTOMER TURNED OFF THE POWER AND SWITCHED TO AN ALTERNATE ADVIA 560 HEMATOLOGY SYSTEM. THERE WERE NO KNOWN REPORTS OF HARM OR INJURY DUE TO THE SMOKE FROM THE ADVIA 560 HEMATOLOGY SYSTEM. THERE WERE NO PATIENT TESTING DELAYS AND NO IMPACT ON PATIENT RESULTS OR PATIENT CARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444229 ↗
• MalfunctionFeb 2, 2018Device Handling Problem; Device Handling Problem

  A SIEMENS HEALTHCARE DIAGNOSTICS (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) BURNED THE LASER CONNECTOR AND LOW LEVEL DATA ACQUISITION (LSDAQ) PRINTED CIRCUIT BOARD (PCB), DURING A TROUBLESHOOTING PROCESS, ON THE ADVIA 560 HEMATOLOGY SYSTEM. A BURNING SMELL WAS EMITTED FROM THE SYSTEM. NO SMOKE OR FLAMES WERE OBSERVED DUE TO THESE BURNT COMPONENTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE BURNING SMELL THAT EMITTED FROM THE ADVIA 560 HEMATOLOGY SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7237856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112755. One submission often covers many models, so check the product and lot details in each record.

• Z-0723-2017 · Oct 21, 2016 · Terminated
  ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.