ADVIA 2120i Hematology SystemRecalls & reported problems across all models

We found 2 models of ADVIA 2120i Hematology System by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and Aug 18, 2024 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

ADVIA 2120i Hematology System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 5, 2021Open, Classified

   Potential Sample Identification (SID) Mismatch with14-Character Barcodes

   Z-1391-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 5, 2021Open, Classified

   Potential Sample Identification (SID) Mismatch with14-Character Barcodes

   Z-1390-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported ADVIA 2120i Hematology System problems

ADVIA 2120i Hematology System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ADVIA® 2120i Hematology System 10285573

  Counter, differential cell
  1 recall28 reports
• ADVIA® 2120i Hematology System 10488923

  Counter, differential cell
  1 recall12 reports

Recent ADVIA 2120i Hematology System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY FALSELY ELEVATED PLATELET RESULT WAS OBTAINED ON AN ADVIA® 2120I HEMATOLOGY SYSTEM, SERIAL NUMBER: (B)(6). THE FALSELY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON THE SAME SYSTEM AND RECOVERED SIMILAR TO THE INITIAL RESULT. THE SAMPLE WAS REPROCESSED A SECOND TIME ON AN ALTERNATE ADVIA® 2120I HEMATOLOGY SYSTEM AND RECOVERED LOWER. THE SAMPLE WAS PROCESSED A THIRD TIME ON A NON-SIEMENS INSTRUMENT AND RECOVERED LOWER. THE LOWER RESULT FROM THE ALTERNATE ADVIA® 2120I HEMATOLOGY SYSTEM WAS CORRECT, REPORTED, AND WAS SIMILAR TO A HISTORICAL RESULT. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999315 ↗
• MalfunctionMar 31, 2023Mechanical Problem; Mechanical Problem

  DUE TO A MISALIGNMENT OF THE BARCODE READER ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, INCORRECT SAMPLE IDENTIFIERS WERE ASSIGNED TO PATIENT SAMPLES ACROSS TWO DAYS (B)(6) 2023. AS A RESULT, 580 SAMPLES WERE REPEATED ON ALTERNATE ADVIA 2120/2120I HEMATOLOGY SYSTEMS, AND 280 REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIANS. SEVEN PATIENTS WERE REDRAWN TO OBTAIN CORRECT RESULTS. 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 16657904 ↗
• MalfunctionMar 31, 2023Mechanical Problem; Mechanical Problem

  DUE TO A MISALIGNMENT OF THE BARCODE READER ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, INCORRECT SAMPLE IDENTIFIERS WERE ASSIGNED TO PATIENT SAMPLES ACROSS TWO DAYS (B)(6) 2023. AS A RESULT, 580 SAMPLES WERE REPEATED ON ALTERNATE ADVIA 2120/2120I HEMATOLOGY SYSTEMS, AND 280 REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). SEVEN PATIENTS WERE REDRAWN TO OBTAIN CORRECT RESULTS. 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 16657605 ↗
• MalfunctionFeb 28, 2023Mechanical Problem; Mechanical Problem

  THE 3M AUTOWASTE PUMP OF THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER EMITTED SMOKE. THE CUSTOMER SWITCHED OFF THE ANALYZER. 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 16456960 ↗
• MalfunctionNov 10, 2022Use of Device Problem; Use of Device Problem

  AS THE CUSTOMER WAS CLEANING THE CENTERING COLLAR ON THE LABORATORY'S ADVIA 2120I HEMATOLOGY SYSTEM, HER HAND SLIPPED AND HER FINGER WAS POKED BY THE AUTOSAMPLER NEEDLE. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT. THE CUSTOMER WASHED THE CUT WITH SOAP AND WATER AND THEN WENT TO THE EMERGENCY ROOM. THE CUSTOMER WAS GIVEN POST EXPOSURE PROPHYLAXIS (PEP) MEDICATION. THE CUSTOMER WAS ALSO GIVEN AN INJECTION WITH A HIGH PLASMA CONCENTRATION TO BOOST HER IMMUNITY. THE CUSTOMER WILL HAVE TO HAVE FOLLOW-UP TESTING AT 1, 3 AND 6 MONTHS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776005 ↗
• MalfunctionApr 18, 2022Leak/Splash; Leak/Splash

  WHILE INSPECTING A LEAK ON THE LABORATORY'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER, THE CUSTOMER WAS SPLASHED ON THE FACE WITH A MIXTURE OF BLOOD AND RINSE SOLUTION. THE CUSTOMER WAS NOT WEARING SAFETY GOGGLES NOR A FACE SHIELD, AND SHE DID NOT KNOW IF THE SPLATTER HIT HER EYES. THE CUSTOMER SUBSEQUENTLY HAD HER BLOOD TESTED AFTER THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137828 ↗
• MalfunctionNov 13, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW PLATELET RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED FOR PLATELET ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PLATELET RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10838428 ↗
• MalfunctionSep 18, 2020Failure to Read Input Signal; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT AN EXTRA CHARACTER IS OCCASIONALLY ADDED TO THE END OF THE PATIENT SAMPLE IDS WHEN THE SAMPLE BARCODE IS READ BY THE AUTOSAMPLER BARCODE READER ON THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE EXTRA CHARACTER ADDED IS RANDOM AND CAN CHANGE FOR THE SAME SAMPLE ID ACROSS MULTIPLE ASPIRATIONS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557073 ↗
• MalfunctionJul 16, 2020High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PLATELET RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE SAMPLE WAS REPEATED ON THE SAME SYSTEM FOR PLATELET, AND RECOVERED HIGHER THAN THE INITIAL DISCORDANT RESULT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PLATELET COUNT WAS THEN ASSESSED MANUALLY, RESULTING LOWER. THIS REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PLATELETS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286895 ↗
• MalfunctionJun 17, 2020Unintended Electrical Shock; Unintended Electrical Shock

  THE CUSTOMER ALLEGED THEY RECEIVED AN ELECTRICAL SHOCK AND NOTICED A BURNING SMELL AFTER TURNING ON THE UNINTERRUPTIBLE POWER SUPPLY (UPS) ATTACHED TO THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. THERE ARE NO REPORTS OF HEALTH CONSEQUENCES FOR THE CUSTOMER AND THE CUSTOMER DID NOT REQUIRE MEDICAL TREATMENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10163727 ↗
• MalfunctionApr 23, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND RED BLOOD CELL (RBC) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER (SERIAL NUMBER: (B)(4)). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS RERUN FOR HGB, HCT, AND RBC ON THE CUSTOMER'S ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). DISCORDANT, FALSELY ELEVATED HGB AND HCT RESULTS WERE ALSO OBTAINED ON A SECOND PATIENT SAMPLE USING THE ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER (SERIAL NUMBER: (B)(4)). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAME SAMPLE WAS REPEATED FOR HGB AND HCT ON THE SAME SYSTEM, RESULTING LOWER. THE SAME SAMPLE WAS THEN RERUN FOR HGB AND HCT ON THE CUSTOMER'S ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, ALSO RESULTING LOWER AND CONFIRMING THE REPEAT RESULTS. 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, FALS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9990459 ↗
• MalfunctionDec 20, 2019Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE DISCORDANT PARAMETERS INCLUDE WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELETS (PLT). THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE TWO PATIENT SAMPLES WERE REPEATED FOR WBC, RBC, HGB, HCT, AND PLT ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM, RESULTING HIGHER. THESE 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 WHITE BLOOD CELLS (WBC), RED BLOOD CELLS (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELETS (PLT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9500555 ↗
• MalfunctionNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT A CUSTOMER SITE AND REPORTED THAT A SAMPLE BARCODE WAS MISREAD ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER BY THE SYSTEM'S HAND HELD BARCODE READER. PATIENT SAMPLE IDENTIFICATION NUMBER (SID) (B)(6) WAS MISREAD AS SID (B)(6). THE ERROR WAS FOUND BY THE CUSTOMER AND THE INITIAL PATIENT RESULTS WERE NOT RELEASED 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 9293462 ↗
• MalfunctionNov 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS AT A CUSTOMER SITE AND REPORTED THAT A SAMPLE BARCODE WAS MISREAD ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER BY THE SYSTEM'S HAND HELD BARCODE READER DURING A MANUAL SAMPLE BARCODE READ. SID (B)(6) WAS MISREAD AS SID (B)(6). 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 9266499 ↗
• MalfunctionAug 8, 2019Use of Device Problem; Use of Device Problem

  A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SUSTAINED A NEEDLESTICK INJURY WHILE THE CSE PERFORMED SERVICE ON A CENTERING COLLAR ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE WOUND WAS CLEANED. THERE ARE NO KNOWN REPORTS OF MEDICAL INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875973 ↗

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