ADVIA® 2120i Hematology System 10488923Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414581965), received between Jul 26, 2017 and Feb 28, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K102644); 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.

Recalls naming this device

1. Mar 5, 2021Class IIOpen, Classified

   Potential Sample Identification (SID) Mismatch with14-Character Barcodes

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

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.

• 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 ↗
• 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 ↗
• MalfunctionJan 30, 2019Use of Device Problem; Use of Device Problem

  AN OPERATOR OF AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER SUSTAINED A NEEDLESTICK INJURY TO THE FINGER WHILE TROUBLESHOOTING AN "AUTOSAMPLER-PUSHPIN JAMMED" ERROR ON THE SYSTEM. THE OPERATOR WAS INJURED BY THE AUTOSAMPLER NEEDLE WHEN THE OPERATOR REMOVED THE CENTERING COLLAR. THE OPERATOR DISINFECTED THE AFFECTED AREA, RECEIVED FIRST AID TREATMENT, AND WILL BE TESTED FOR INFECTIOUS DISEASES [(B)(6)]. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER SUSTAINING A NEEDLESTICK INJURY WHILE TROUBLESHOOTING ERROR "AUTOSAMPLER-PUSHPIN JAMMED" ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8288469 ↗
• MalfunctionNov 8, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THERE WAS AN OVER RECOVERY OF PLATELET RESULTS OBTAINED ON PATIENT SAMPLES ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. THE SAMPLES WERE REPEATED AFTER THE CUSTOMER RECALIBRATED THE SYSTEM, AND A LOWER RATE OF OVER RECOVERING PLATELET RESULTS WAS OBTAINED. IT IS UNKNOWN IF ANY OF THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OVER RECOVERING PLATELET RESULTS ON PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053437 ↗
• MalfunctionAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT AN OPERATOR TRIPPED ON THE FLOOR AND FELL NEAR THE INPUT QUEUE OF AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. THE OPERATOR SUSTAINED AN INJURY TO THE ARM FROM THE METAL EDGE OF THE SYSTEM; THE OPERATOR APPLIED AN ADHESIVE TAPE TO THE CUT AND WAS TESTED FOR INFECTIOUS DISEASES. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE OPERATOR'S INJURY TO THE ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770173 ↗
• MalfunctionJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT FLAGGED, DISCORDANT BASOPHIL/LOBULARITY WHITE BLOOD CELL COUNT (WBCB) AND DIFFERENTIALS RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER WITH SERIAL NUMBER (SN) (B)(4). A DIFFERENCE BETWEEN THE PEROXIDASE CHANNEL WHITE BLOOD CELL COUNT (WBCP) RESULT AND WBCB RESULT WAS OBSERVED. THE CUSTOMER REPORTED THAT THE WBCP RESULT WAS CORRECT AND CORRESPONDED WITH THE RESULT OBTAINED USING THE BLOOD FILM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER ALLEGED THAT THE SAMPLE WAS RERUN ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER WITH SN (B)(4) AND THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER WITH SN (B)(4), RESULTING SIMILARLY. IT IS UNKNOWN IF OTHER RESULTS IN THE COMPLETE BLOOD COUNT (CBC) WERE DISCORDANT AND THE REPEAT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS OBTAINED ON THE PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649962 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT FLAGGED, DISCORDANT BASOPHIL/LOBULARITY WBC COUNT (WBCB) AND DIFFERENTIALS RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER WITH SERIAL NUMBER (SN): (B)(4). A DIFFERENCE BETWEEN THE PEROXIDASE CHANNEL WBC COUNT (WBCP) RESULT AND WBCB RESULT WAS OBSERVED. THE CUSTOMER REPORTED THAT THE WBCP RESULT WAS CORRECT AND CORRESPONDS WITH THE RESULT OBTAINED USING THE BLOOD FILM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SN: (B)(4), RESULTING IDENTICALLY. IT IS UNKNOWN IF OTHER RESULTS IN THE COMPLETE BLOOD COUNT (CBC) WERE DISCORDANT. A DIFFERENT SAMPLE FROM THE PATIENT WAS RUN ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SN: (B)(4) AND THE WBCP AND WBCB RESULTS CORRELATED WITH EACH OTHER; A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN(S). THE REPEAT CBC RESULTS, OBTAINED ON THE INITIAL SAMPLE, AND THE CBC RESULTS, OBTAINED ON THE OTHER SAMPLE, WERE NOT PROVIDED BY THE CUSTOMER AND THE RESULTS IN THE CORRECTED REPORT ARE UNKNOWN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7604477 ↗
• MalfunctionJan 29, 2018Mechanical Problem; Mechanical Problem

  DISCORDANT, FALSELY LOW WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. OTHER PARAMETERS IN THE INITIAL COMPLETE BLOOD COUNT (CBC) WERE ALSO IMPACTED BY THIS EVENT. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS AS THE PHYSICIAN(S) EXPECTED AN ELEVATED HGB RESULT. THE SAME SAMPLE WAS MANUALLY RERUN ON THE SAME SYSTEM, RESULTING HIGHER THAN THE INITIAL RESULTS. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON THE SAME SYSTEM, RESULTING HIGHER THAN THE INITIAL RESULTS. THE RESULTS OBTAINED ON THE REDRAWN SAMPLE WERE EXPECTED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS ON MULTIPLE PARAMETERS OF THE CBC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226963 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA 2120I HEMATOLOGY SYSTEMS. THE SAME SAMPLE WAS RERUN ON ONE OF THE ADVIA 2120I SYSTEM, RESULTING IN ANOTHER LOW HGB RESULT. A DISCORDANT, FALSELY LOW HGB RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. OTHER PARAMETERS IN THE COMPLETE BLOOD COUNT (CBC) WERE POTENTIALLY AFFECTED, BUT IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND THE CORRECT RESULTS FOR THE OTHER PARAMETERS ARE UNKNOWN. IT IS UNKNOWN IF A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976755 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA 2120I HEMATOLOGY SYSTEMS. THE SAME PATIENT SAMPLE WAS RERUN ON ONE OF THE ADVIA 2120I SYSTEM, RESULTING IN ANOTHER DISCORDANT LOW HGB RESULT. A DISCORDANT, FALSELY LOW HGB RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. OTHER PARAMETERS IN THE COMPLETE BLOOD COUNT (CBC) WERE ALSO AFFECTED, BUT IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND THE CORRECT RESULTS FOR THE OTHER PARAMETERS ARE UNKNOWN. THE PATIENT'S BLOOD WAS REDRAWN AND RUN ON BOTH SYSTEMS, RESULTING HIGHER THAN THE INITIAL DISCORDANT RESULTS. THE RESULTS OBTAINED USING THE REDRAWN PATIENT SAMPLE WAS EXPECTED AND ALIGNED WITH THE PATIENT'S CLINICAL HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976754 ↗
• MalfunctionOct 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON TWO ADVIA 2120I HEMATOLOGY SYSTEMS. THE SAME SAMPLE WAS RERUN ON ONE OF THE ADVIA 2120I SYSTEM, RESULTING LOWER. A DISCORDANT, FALSELY LOW HGB RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. OTHER PARAMETERS IN THE COMPLETE BLOOD COUNT (CBC) WERE ALSO AFFECTED, BUT IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND THE CORRECT RESULTS FOR THE OTHER PARAMETERS ARE UNKNOWN. THE PATIENT BLOOD WAS REDRAWN AND RUN ON BOTH SYSTEMS, RESULTING IN HIGHER HGB RESULTS. A CORRECTED REPORT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976752 ↗
• MalfunctionJul 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FLAGGED DISCORDANT, FALSELY LOW HEMOGLOBIN (HGB) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. THE HGB RESULT RECOVERED OUTSIDE OF THE CUSTOMER NORMAL REFERENCE RANGE AND THE SYSTEM FLAGGED THE COMPLETE BLOOD COUNT (CBC). THE HGB RESULT WAS VALIDATED BY THE CUSTOMER AND REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE PATIENT BLOOD WAS RE-DRAWN AFTER HE WAS ADMITTED INTO THE HOSPITAL AND RUN ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM. THE REPEATED RESULT ON THE ALTERNATE SYSTEM RECOVERED HIGHER. THE ORIGINAL PATIENT SAMPLE WAS RE-RUN, RESULTING SIMILAR TO THE RESULT FROM THE RE-DRAWN SAMPLE. THE CORRECTED RESULT WAS PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW HGB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745191 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102644. One submission often covers many models, so check the product and lot details in each record.

• Z-1402-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1395-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1386-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1389-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1388-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1393-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1391-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1401-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1392-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1398-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1387-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1403-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1400-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1396-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1397-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11

…and 5 more.