ADVIA 2120i with SAA Autosampler 11219530Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00630414019789), received between Jul 21, 2017 and Jan 24, 2024 — classified as 7 malfunctions.

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

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

19 other recalls cover devices cleared under the same FDA submission (K162977); 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-1394-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2024Leak/Splash; Leak/Splash

  AS THE CUSTOMER¿S ADVIA 2120I HEMATOLOGY SYSTEM WAS PERFORMING AUTOMATIC CLOSED TUBE SAMPLING (ACTS), FLUID SPRAYED OUT OF THE ACTS AREA ONTO THE CUSTOMER¿S FACE AND MOUTH. THE ACTS DOOR WAS OPEN. 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 18574882 ↗
• MalfunctionDec 28, 2023High Test Results; High Test Results

  AN ERRONEOUS, FALSELY ELEVATED PLATELET (PLT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED, AS A LOWER RESULT WAS EXPECTED SINCE THE PATIENT HAD MALARIA. THE SAMPLE WAS RUN ON A NON-SIEMENS SYSTEM AND THE PLT RESULT ALSO RECOVERED FALSELY ELEVATED. THE SAMPLE WAS REPEATED FOR PLT ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM AS WELL AS ON THE NON-SIEMENS SYSTEM, RECOVERING LOWER. THE LOWER PLT 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 FALSELY ELEVATED PLATELET RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409638 ↗
• MalfunctionMar 21, 2023High Test Results; High Test Results

  A DEPRESSED WHITE BLOOD CELL COUNT (WBC) RESULT OF 0.06 X10^9/L WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AT 2:59:51 AM. AT 2:47:35 PM, ANOTHER SAMPLE FROM THE PATIENT WAS PROCESSED ON THE SAME INSTRUMENT AND PRODUCED A FLAGGED FALSELY ELEVATED WBC RESULT, WHICH DID NOT MATCH THE BLOOD FILM EXAMINATION PERFORMED EARLIER ON THE SAMPLE. THE FALSELY ELEVATED WBC RESULT WAS REPORTED TO THE PHYSICIAN(S). THE NEXT DAY, A NEW SAMPLE FROM THE SAME PATIENT PRODUCED A FLAGGED, FALSELY ELEVATED WBC RESULT ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE. THE WBC RESULT ALSO DID NOT CORRELATED WITH THE BLOOD FILM PREVIOUSLY REVIEWED FOR THIS SAMPLE. THE DISCREPANCY BETWEEN THE WBC RESULTS WAS NOTED. MDR 2517506-2023-00099 PERTAINS TO THE SAME PATIENT AND WAS FILED FOR THE WBC RESULT OBTAINED ON 10-FEB-2023. HOWEVER, THE PHYSICIAN(S) PERFORMED A BONE MARROW ASPIRATION ON THE PATIENT BEFORE THE WBC HAD BEEN CONFIRMED AND VALIDATED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583314 ↗
• MalfunctionMar 21, 2023High Test Results; High Test Results

  A FLAGGED, FALSELY ELEVATED WHITE BLOOD CELL COUNT (WBC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE. THE WBC RESULT DID NOT MATCH THE BLOOD FILM PREVIOUSLY PERFORMED ON THE SAMPLE AND THE DISCREPANCY BETWEEN THE WBC RESULTS WAS NOTED. HOWEVER, THE PHYSICIAN(S) PERFORMED A BONE MARROW ASPIRATION ON THE PATIENT BEFORE THE WBC HAD BEEN CONFIRMED AND VALIDATED. THIS PATIENT PERTAINS TO THE SAME PATIENT MENTIONED IN MDR 2517506-2023-00098. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVE NOT BEEN VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583313 ↗
• MalfunctionFeb 26, 2019Use of Device Problem; Use of Device Problem

  CUSTOMER REPORTED, WHILE PERFORMING THE BACK-FLUSH CLEANING PROCEDURE ON THE ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE, DISTILLED WATER SPRINKLED ON THE OPERATOR'S FACE. ON THE DATE OF THE EVENT, THE OPERATOR WORE PERSONAL PROTECTIVE EQUIPMENT (PPE) BUT DID NOT WEAR SAFETY GLASSES OR A SAFETY MASK. THE OPERATOR RINSED THEIR FACE WITH TAP WATER. THE OPERATOR DID NOT RECEIVE INFECTIOUS DISEASES TREATMENT NOR MEDICAL ATTENTION/TREATMENT DUE THE EXPOSURE TO THE DISTILLED WATER. THERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISTILLED WATER SPRINKLED ON THE OPERATOR'S FACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8371415 ↗
• MalfunctionOct 4, 2018Device Handling Problem; Device Handling Problem

  AN OPERATOR OF AN ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE WAS EXPOSED TO ADVIA EZ WASH SOLUTION WHILE PERFORMING MAINTENANCE ON THE SYSTEM; THE ADVIA EZ WASH SOLUTION SPLASHED ONTO THE CUSTOMER'S FACE AND EYE WHEN THE SOLUTION BOTTLE SLIPPED. THE OPERATOR RINSED HER EYE AND SOUGHT OPHTHALMIC CONSULTATION. THE PHYSICIAN(S) PRESCRIBED A TREATMENT OF ANTIBIOTIC EYE DROPS, LUBRICANT MOISTURIZING EYE DROPS, EYE DROPS FOR DRY EYES AND VITAMIN A OINTMENT FOR A MONTH TO THE OPERATOR. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE OPERATOR'S EXPOSURE TO ADVIA EZ WASH SOLUTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7935851 ↗
• MalfunctionJul 21, 2017Mechanical Problem; Mechanical Problem

  A DISCORDANT, FALSELY LOW PLATELET (PLT) RESULT AND A DISCORDANT, FALSELY ELEVATED HEMATOCRIT (HCT) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON THE ADVIA 2120I (ROHS) HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS RE-RUN ON THE SAME SYSTEM 3 TIMES AND ON AN ALTERNATE ADVIA 2120I SYSTEM 4 TIMES. UPON REPEAT, THE PLATELET RESULTS RECOVERED HIGHER, WHILE THE HEMATOCRIT RESULT RECOVERED LOWER. THE CORRECTED RESULTS FROM THE ALTERNATE ADVIA 2120I SYSTEM WERE PROVIDED TO THE PHYSICIAN. THE INTERNAL QUALITY CONTROLS RECOVERED WITHIN RANGE WHEN THE DISCORDANT RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT LOW PLATELET (PLT) AND DISCORDANT ELEVATED HEMATOCRIT (HCT) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6732478 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162977. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-1399-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, 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-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-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-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-1404-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, 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-1405-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
• Z-1390-2021 · Mar 5, 2021 · Open, Classified
  ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, 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

…and 4 more.