ADVIA 2120i with DAA Autosampler 11219529Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00630414019772), received between Oct 15, 2021 and Jan 3, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 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-1395-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Smoking; Smoking

  THE CUSTOMER REPORTED AUTOSAMPLER FAILURE AND VISIBLE SMOKE INSIDE THE ADVIA 2120I. NO VISIBLE FLAMES OR SPARKS WERE NOTED. THERE WAS NO DELAY IN PATIENT TESTING AS THE CUSTOMER HAS A BACK-UP INSTRUMENT, NO IMPACT TO PATIENT RESULTS, NO INJURIES TO THE OPERATOR AND NO DAMAGE TO OTHER LABORATORY EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072918 ↗
• MalfunctionApr 8, 2024Failure to Read Input Signal; Failure to Read Input Signal

  THE CUSTOMER REPORTED THAT THERE WAS A WRONG ASSOCIATION BETWEEN SAMPLE ID AND PATIENT ID FOR TWO PATIENTS ON AN ADVIA 2120I HEMATOLOGY SYSTEM: 1) SAMPLE ID: (B)(6); PATIENT ID: (B)(6). 2) SAMPLE ID: (B)(6); PATIENT ID: (B)(6). IN BOTH CASES THE ADVIA 2120I HEMATOLOGY SYSTEM READ PATIENT ID (B)(6) (WITHOUT THE LAST NUMBERS 4 AND 1). FOR THIS REASON, ON THE ADVIA 2120I SOFTWARE, THERE WAS THE SAME PATIENT NAME FOR BOTH THE SAMPLE IDS. THE INCORRECT RESULTS WERE NOT REPORTED OUT TO THE PHYSICIAN(S). 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 19062053 ↗
• MalfunctionDec 18, 2023High Test Results; High Test Results

  A FALSELY ELEVATED PLATELET (PLT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM (SERIAL NUMBER (B)(6). THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS REPEATED ON THE SAME ADVIA 2120I HEMATOLOGY SYSTEM. ADDITIONALLY, THE ORIGINAL SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA 2120I HEMATOLOGY SYSTEM (SERIAL NUMBER (B)(6) AND AN ALTERNATE METHOD. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. THE 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 FALSELY ELEVATED PLATELET (PLT) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345811 ↗
• MalfunctionSep 29, 2023High Test Results; High Test Results

  A FALSELY ELEVATED PLATELET (PLT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS PROCESSED FOR PLT, RECOVERING LOWER. THE LOWER RESULT FROM THE REDRAWN SAMPLE WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THE FOLLOWING DAY, THE INITIAL SAMPLE WAS REPEATED FOR PLT AND ALSO RECOVERED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED PLT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848269 ↗
• MalfunctionAug 21, 2023Smoking; Smoking

  THE CUSTOMER REPORTED SMOKE EMITTED FROM AN ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER DUE TO A MALFUNCTIONED BLACK WIRE FROM THE AUTOSAMPLER. THE CUSTOMER CONFIRMED THAT THERE WERE NO VISIBLE FLAMES ASSOCIATED WITH THE SMOKE. THE CUSTOMER HAD A BACKUP INSTRUMENT TO PROCESS SAMPLES WHEN THE INSTRUMENT WAS DOWN. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586023 ↗
• MalfunctionJul 26, 2023Use of Device Problem; Use of Device Problem

  WHILE TROUBLESHOOTING A LEAK ON THE CUSTOMER¿S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE, AN OPERATOR SUSTAINED A NEEDLESTICK INJURY WHEN THEY REMOVED THE CENTERING COLLAR. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. THE CUSTOMER WENT TO THE ACCIDENT AND EMERGENCY DEPARTMENT, WHERE THEY WERE GIVEN A COURSE OF ANTI-VIRALS. THE OPERATOR WAS ALSO GIVEN HEPATITIS B VACCINATION ON THE FOLLOWING DAY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398476 ↗
• MalfunctionMay 19, 2023Sparking; Sparking

  ONE OF THE THREE TUBES OF THE STAINING FLUID RESERVOIR OF THE ADVIA AUTOSLIDE OF THE CUSTOMER¿S ADVIA 2120I HEMATOLOGY SYSTEM CAME OFF AND GOT CAUGHT IN THE SYSTEM'S PRINTER CONNECTOR BOARD. THE PRINTER SUBSEQUENTLY SPARKED. THERE ARE NO KNOWN REPORTS OF INJURY, DELAY IN TESTING, NOR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962516 ↗
• MalfunctionJan 31, 2023Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT WASTE SPILLED ON THEIR LEG AND FOOT WHILE THEY WERE MANUALLY EMPTYING THE WASTE FROM THE LABORATORY'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THE CUSTOMER WASHED OFF THE AREA WHERE THE WASTE SPILLED AND REPORTED THAT THEIR SKIN WAS RED. THE CUSTOMER WENT TO EMPLOYEE HEALTH AND WAS NOT TREATED FOR BIOHAZARD EXPOSURE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274800 ↗
• MalfunctionJun 9, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A PLATELET CLUMP FLAG WAS NOT TRIGGERED ON THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER WHEN A PATIENT SAMPLE WAS RUN FOR PLATELET, EVEN THOUGH PLATELET CLUMPING WAS SEEN ON THE PATIENT'S BLOOD FILM. DUE TO THE PLATELET CLUMPING, IT IS UNKNOWN IF THE PLATELET RESULT WAS CONSIDERED DISCORDANT OR CORRECT. THE RESULT WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14647341 ↗
• MalfunctionOct 15, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER WAS SPLASHED IN THE EYE WITH MIXTURE OF BLOOD AND REAGENT AFTER OPENING THE AUTOSAMPLER SAFETY SHIELD OF THE CUSTOMER'S ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER. THE CUSTOMER HAD NOTICED THAT THE SAMPLES COMING OUT OF THE SYSTEM WERE CONTAMINATED WITH BLOOD AND REAGENT, WHICH IS WHAT PROMPTED THE CUSTOMER TO OPEN THE SAFETY SHIELD. A SAFETY VISOR WAS NOT READILY AVAILABLE TO WEAR WHEN INVESTIGATING THE PROBLEM, LEADING TO ASPIRATE GOING INTO CUSTOMER'S EYE. THE CUSTOMER FOLLOWED FIRST AID PROTOCOL BY WASHING THEIR EYE WITH WARM WATER AND WENT TO THE EMERGENCY DEPARTMENT. THE CUSTOMER WAS PUT ON A 28 DAY COURSE PROPHYLACTIC TREATMENT FOR BLOOD BORNE VIRUSES AS A PRECAUTIONARY MEASURE. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639460 ↗

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-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-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
• 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-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
• 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-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-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-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-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-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-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-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-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

…and 4 more.