COULTER AcTRecalls & reported problems across all models

We found 5 models of COULTER AcT by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Oct 7, 2016 and Jun 25, 2024 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 reports).

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

Most reported COULTER AcT problems

COULTER AcT models

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

• COULTER AcT diff 2

  Counter, Differential Cell
  25 reports
• COULTER AcT diff 12, diff 16

  Counter, Differential Cell
  4 reports
• COULTER AcT 5diff

  Counter, Differential Cell
  4 reports
• COULTER AcT 5diff

  Counter, Differential Cell
  1 report
• COULTER AcT 5diff

  Counter, Differential Cell
  1 report

Recent COULTER AcT adverse event reports

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

• MalfunctionJun 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TWO PATIENT SAMPLES RECOVERED WITH A HIGH PLATELET (PLT) RESULT WHEN CYCLED ON THE ACT DIFF 2 INSTRUMENT. THE CUSTOMER ALSO REPORTED START UP FAILED FOR PLATELETS FOLLOWING THE EVENT. NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. NO ADVERSE EVENT OCCURRED. THE CUSTOMER REPORTED TWO PATIENT SAMPLES RECOVERED WITH A HIGH PLATELET (PLT) RESULT WHEN CYCLED ON THE ACT DIFF 2 INSTRUMENT. THE CUSTOMER ALSO REPORTED START UP FAILED FOR PLATELETS FOLLOWING THE EVENT. THE FAILURE MODE IS UNKNOWN. HOWEVER, THE REPLACEMENT OF THE REAGENT PAK RESOLVED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605577 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED PATIENT SAMPLES RECOVERED WITH HIGH WBC RESULTS AND SUSPECT MESSAGING WHEN CYCLED ON THEIR ACT DIFF 2 HEMATOLOGY INSTRUMENT COMPARED TO A RERUN ON THE SAME INSTRUMENT. DOCUMENTATION INDICATES FOUR ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY SINCE (B)(6) 2023. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT FOR THREE OF THE PATIENTS (PATIENT 1, 2, AND 3).THERE WAS A CHANGE IN PATIENT TREATMENT FOR ONE PATIENT (PATIENT 4). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND GIVEN ANTIBIOTICS DUE TO THE ERRONEOUS FLAGGED HIGH WBC RESULTS REPORTED TO THE PHYSICIAN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE NEXT DAY. PATIENT SAMPLE 1 - PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 1) RECOVERED WITH HIGH WBC, HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS WITH SUSPECT MESSAGING COMPARED TO A RERUN ON THE SAME INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. ALL OTHER CBC PARAMETERS CORRELATED BETWEEN RUNS. PATIENT SAMPLE 2- PRINTOUTS ALSO RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 2) RECOVERED WITH HIGH WBC AND LOW PLATELET (PLT) RESULTS WITH VOTE OUTS FOR THE RBC, HCT, MEAN CORPUSCULAR HEMOGLOBIN (MCH) AND MEAN CORPUSCULAR HEMOGLOBIN CO

  Patient problems: Abdominal Pain; Fever

  MAUDE report 16811094 ↗
• MalfunctionMar 15, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PATIENT SAMPLES RECOVERED WITH ERRONEOUS HIGH PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR ACT DIFF 2 HEMATOLOGY INSTRUMENT. IT WAS CONFIRMED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PRINT OUTS OF THE EVENT WERE REQUESTED BUT NOT PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16547955 ↗
• MalfunctionDec 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THEIR ACT DIFF 2 HEMATOLOGY INSTRUMENT QUESTIONABLE GENERATED HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THE RESULTS IN QUESTION WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORTED CHANGE OR EFFECT ON PATIENT TREATMENT. THERE WAS NEITHER DEATH NOR SERIOUS INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908898 ↗
• MalfunctionOct 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE LOW CONTROL AND PATIENT SAMPLES RECOVERED WITH HIGH PLATELET (PLT) RESULTS WHEN CYCLED ON THE ACT DIFF 2 INSTRUMENT. ERRONEOUS PLT RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, PER CONVERSATION WITH THE CUSTOMER ON (B)(6) 2022, THERE WAS NOT DEATH, INJURY OR CHANGE TO PATIENT TREATMENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655528 ↗
• MalfunctionSep 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE ACT DIFF 2 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS FOR ONE PATIENT SAMPLE. THE INSTRUMENT ALSO FAILED PLT BACKGROUNDS. IT WAS CONFIRMED THAT ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15458921 ↗
• MalfunctionJun 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THEIR ACT DIFF 2 INSTRUMENT GENERATED ERRONEOUS HIGH PLT RESULTS ON PATIENT SAMPLES AND CONTROLS . THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. DATA PRINTOUTS WERE REQUESTED BUT THE CUSTOMER WAS UNABLE TO PROVIDE THEM. IT COULD NOT BE CONFIRMED IF THERE WERE ANY ERROR MESSAGES OR FLAGGING. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712900 ↗
• MalfunctionApr 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE FIELD SERVICE ENGINEER (FSE) REPORTED PLATELET (PLT) BACKGROUND AND CONTROL SAMPLES WERE VERY HIGH ON THE CUSTOMER¿S ACT 5DIFF AL ANALYZER AFTER CUSTOMER INSTALLED USED DILUENT REAGENT. THERE WAS NO REPORT OF AN ADVERSE EVENT. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE FSE PROVIDED ONE EXAMPLE SHOWING THE REPORTED ELEVATED PLT RESULT ISSUE ON A PATIENT SAMPLE AND THE INSTRUMENT HAD FAILED STARTUP FOR PLT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247004 ↗
• MalfunctionDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE TRAVERSE ON THE ACT 5 DIFF CP HEMATOLOGY ANALYZER WAS NOT REACHING HOME. HIGH UNFLAGGED PLATELET (PLT) VALUES AND PLT VOTE OUTS WERE ALSO RECOVERED FOR PATIENT SAMPLES. ERRONEOUS RESULTS GENERATED FROM THE ANALYZER, HOWEVER, ERRONEOUS RESULTS REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. INSTRUMENT DATA OF THREE (3) PATIENT SAMPLES WERE PROVIDED FOR REVIEW. ON (B)(6) 2021, PATIENT 1 SAMPLE WAS RUN IN CBC MODE ON THE ACT 5 DIFF CP RECOVERING HIGH PLT RESULTS OF 724 X 103 CELLS/L WITH NO PLT SPECIFIC INSTRUMENT SUSPECT MESSAGES. THE PATIENT¿S SAMPLE WAS RERUN (X3) ON THE SAME DAY RECOVERING LOWER PLT RESULTS OF 192, 123 AND 105 X 103 CELLS/L RESPECTIVELY. THE CUSTOMER PERFORMED SHUTDOWN, STARTUP AND QC WHICH RECOVERED WITHIN THE EXPECTED RANGE. THE PATIENT¿S SAMPLE WAS RERAN RECOVERING A PLT RESULT OF 105 X 103 CELLS/L WHICH WAS CONSIDERED CORRECT. ON (B)(6) 2021, PATIENT 2 AND PATIENT 3 SAMPLES WERE RUN ON THE ACT 5 DIFF CP INSTRUMENT RECOVERING RESULTS WITH PLT VOTE OUTS, DIFF ¿R¿ FLAGS, PLT INTERPRETATION NOT POSSIBLE, NRBC AND PLT AGGREGATES INSTRUMENT INTERPRETIVE MESSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006904 ↗
• MalfunctionSep 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INITIALLY REPORTED H&H WAS NOT MATCHING FOR PATIENT SAMPLES RUN ON THE ACT5DIFF AL INSTRUMENT. THE CUSTOMER ALSO STATED A GRINDING NOISED WAS OBSERVED COMING FROM THE INSTRUMENT. THE FIELD SERVICE ENGINEER STATED THAT UPON ARRIVAL HE FOUND THE INSTRUMENT OUT OF USE AND REVIEWED QUESTIONABLE PATIENT SAMPLES WITH EXTREMELY HIGH RBC AND PLT VALUES. THERE WERE A TOTAL OF FOUR ERRONEOUS PATIENT RESULTS GENERATED AND ONE RESULT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF AN ADVERSE EVENT OR IMPACT TO PATIENT TREATMENT. INSTRUMENT DATA OF THE ERRONEOUS RESULTS HAS NOT BEEN PROVIDED FOR REVIEW, AS A RESULT INSTRUMENT FLAGGING COULD NOT BE ASSESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543816 ↗
• MalfunctionSep 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING HIGH PLT RESULTS FOR PATIENT SAMPLES RUN ON THE AC*T DIFF 2 INSTRUMENT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WAS NO IMPACT TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12503061 ↗
• MalfunctionJul 8, 2021Priming Problem; Priming Problem

  THE CUSTOMER REPORTED THAT THE RESULTS GENERATED ON THEIR ACT DIFF HEMATOLOGY INSTRUMENT FOR TWO PATIENT SAMPLES WERE ERRONEOUSLY HIGH. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. ONE OF THE PATIENTS WERE INITIALLY SENT TO THE HOSPITAL EMERGENCY ROOM BUT THE RECOMMENDATION WAS REVERSED ONCE THE CUSTOMER IDENTIFIED AN INSTRUMENT PROBLEM. NO OTHER IMPACT TO PATIENT OR TREATMENT WAS REPORTED. ADDITIONAL INFORMATION ABOUT THE IMPACTED PATIENT WAS REQUESTED. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ATTEMPTED TO GET THE DETAILS REGARDING THE PATIENT WHO WENT TO ER BUT WAS UNABLE TO GET ADDITIONAL INFORMATION FROM THE CUSTOMER..

  Patient problems: Insufficient Information

  MAUDE report 12140601 ↗
• MalfunctionDec 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES RUN ON THE ACT DIFF 2 ANALYZER AFTER ONSITE SERVICE. THERE WERE NO ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963655 ↗
• MalfunctionNov 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING ERRONEOUS HIGH PLATELET (PLT) RESULTS FOR A SINGLE PATIENT SAMPLE RUN ON THE ACT DIFF 2 ANALYZER AFTER ONSITE SERVICE. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10843033 ↗
• MalfunctionSep 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING HIGH ERRONEOUS PLT RESULTS ON 2 PATIENT SAMPLES RUN ON THE AC*T DIFF 2 INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THE FIRST PATIENT¿S SAMPLE (ID ENDING IN 4192 ACTDIFF 2) GENERATED A PLT OF 507, THE RERUN RESULT WAS 364. THE SECOND PATIENT (ID ENDING IN 5165 ACTDIFF 2) GENERATED A PLT OF 512, THE RERUN RESULT WAS 367.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512496 ↗

Other Beckman Coulter, Inc. products

• Cytomics FC5002 models · 1,337 reports
• DxC AU4 models · 632 reports · 8 recalls
• MicroScan10 models · 7 reports · 9 recalls
• Synchron7 models · 4 reports · 5 recalls
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2 models · 5 reports · 4 recalls
• UniCel DxH4 models · 74 reports · 2 recalls
• Access AccuTnI+32 models · 165 reports
• REMISOL Advance2 models · 0 reports · 2 recalls