COULTER AcT diff 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 15099590264796), received between Oct 21, 2016 and Jun 25, 2024 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K990352); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 9, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING ASTERISKS (*) FLAGS ON THE PLT AND MPV PARAMETERS FOR QC AND PATIENT SAMPLES RUN ON THE ACT DIFF 2 INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255907 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED HIGH PLATELETS (PLT) RESULTS FOR PATIENTS SAMPLES ON THEIR COULTER AC·T DIFF 2 ANALYZER. NEITHER PATIENT RESULTS OR RAW DATA WERE PROVIDED BY THE CUSTOMER. THERE WERE NO ERRONEOUS PATIENT¿S RESULTS RELEASED FROM LAB NOR EFFECT TO PATIENT TREATMENT.

  Patient problems: No Consequences Or Impact To Patient; Test Result

  MAUDE report 8558391 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PLATELETS (PLT) RUNNING HIGH FOR ALL PATIENT SAMPLES AND QC ON THEIR COULTER AC·T DIFF 2 ANALYZER. ERRONEOUS RESULTS WITH HIGH PLATELETS COUNT WERE GENERATED FOR THIS EVENT. HOWEVER, THE ERRONEOUS RESULTS WERE IDENTIFIED BY THE CUSTOMER AND WERE NOT RELEASED FROM LAB. THERE WAS NO IMPACT TO PATIENT TREATMENT AS A RESULT OF THE REPORTED EVENT. NEITHER PATIENT DATA OR RAW DATA WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; Test Result

  MAUDE report 8558389 ↗
• MalfunctionMar 16, 2019Output Problem; Output Problem

  THE CUSTOMER REPORTED ERRATIC HEMOGLOBIN (HGB) AND PLATELET (PLT) RESULTS FOR PATIENT SAMPLES ON THEIR AC*T DIFF 2 INSTRUMENT. RESULTS WOULD NOT REPRODUCE ON PATIENTS. THERE WERE NO RESULTS REPORTED OUTSIDE OF THE LAB. CUSTOMER IS NOT AWARE OF ANY IMPACT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT DATA HAS BEEN REQUESTED BUT NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426702 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED ISSUES WITH PLATELET (PLT) QUALITY CONTROL RESULTS ON A COULTER AC·T DIFF 2 ANALYZER. THE CUSTOMER CALLED CUSTOMER TECHNICAL SUPPORT AND REFUSED TO ADJUST THEIR CALIBRATION VALUES AS RECOMMENDED, ADN REQUESTED SERVICE. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AT THE CUSTOMER'S SITE AND OBSERVED FALSELY ELEVATED PLT VALUES ON PATIENT SAMPLES. ERRONEOUS RESULTS WERE NOT RELEASED FROM THE LABORATORY AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS AND PATIENT DEMOGRAPHIC DATA WERE NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920669 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  CUSTOMER REPORTED THAT THE PLATELET (PLT) RESULTS WERE INTERMITTENTLY ERRONEOUSLY HIGH WHILE DURING PATIENT SAMPLE RUNS ON THEIR COULTER AC·T DIFF 2 ANALYZER. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULTS OF THIS EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Test Result

  MAUDE report 7728327 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER AC·T DIFF 2 ANALYZER WAS GENERATING HIGH PLATELET (PLT) RESULTS COMPARED TO ANOTHER INSTRUMENT IN THE LABORATORY. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726918 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER AC·T DIFF 2 ANALYZER GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726912 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER AC·T DIFF 2 ANALYZER GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. INSTRUMENT PRINTOUTS OF PATIENT RESULTS OR CONTROLS WERE NOT PROVIDED FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726907 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER AC·T DIFF 2 ANALYZER GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON THREE PATIENT SAMPLES. THE CUSTOMER ALSO STATED THAT CONTROLS WERE FAILING FOR PLTS AFTER THE EVENT WAS IDENTIFIED. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726894 ↗
• MalfunctionJul 12, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED HAVING AN ONGOING ISSUE WITH ERRONEOUSLY HIGH PLATELET (PLT) FOR QC AND PATIENT SAMPLES ON THEIR COULTER AC·T DIFF 2 ANALYZER. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT AND QC DATA WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Test Result

  MAUDE report 7684078 ↗
• MalfunctionMay 17, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE COULTER ACT DIFF 2 ANALYZER GENERATED HIGH PLATELET (PLT) RESULTS FOR ONE PATIENT SAMPLE COMPARED TO A RESULT FROM A DXH800 INSTRUMENT.. PER THE FIELD SERVICE ENGINEER (FSE) THE CUSTOMER RERUNS ALL OF THE SAMPLES IN A DXH800 INSTRUMENT. THE CUSTOMER FOUND THAT THE ACT DIFF 2 GAVE HIGHER PLT RESULTS WITHOUT ANY FLAGS OR ERROR MESSAGES. PER THE FSE, THE ACT DIFF 2 INSTRUMENT HAD ALSO FAILED BACKGROUND CHECKS PRIOR TO RUNNING THE PATIENT SAMPLE. THE CUSTOMER DID NOT PROVIDE ANY PRINTOUTS OF THE RESULTS. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Test Result

  MAUDE report 7523485 ↗
• MalfunctionMar 23, 2018Incorrect Or Inadequate Test Results; High Test Results; Incorrect Or Inadequate Test Results; High Test Results

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELET (PLT) RESULTS WERE GENERATED FOR 22 PATIENTS ON A COULTER AC·T DIFF 2 ANALYZER. WHEN THE SAMPLES WERE RE-RUN ON A DIFFERENT INSTRUMENT, RESULTS WERE APPROXIMATELY 300 UNITS LOWER, ACCORDING TO THE CUSTOMER. CONTROLS RUN PRIOR TO THE EVENT WERE WITHIN SPECIFICATION; HOWEVER, THE CUSTOMER RE-RAN CONTROLS AFTER THE EVENT AND CONTROLS FLAGGED HIGH FOR PLT. RESULT PRINTOUTS WERE PROVIDED BY THE CUSTOMER, BUT CORRECTED RESULTS WERE NOT PROVIDED FOR COMPARISON. THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT REPORTED IN CONNECTION TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7367594 ↗
• MalfunctionOct 21, 2016Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED FINDING AN UNCONTAINED LEAK OF ABOUT 5CC OF FLUID ON TOP OF THE SAMPLE TUBES OF A COULTER AC T DIFF 2 ANALYZER WHILE PROCESSING SAMPLES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT WHEN THE LEAK WAS FOUND, AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

  Patient problems: Not Applicable

  MAUDE report 6048968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990352. One submission often covers many models, so check the product and lot details in each record.

• Z-0339-05 · Dec 3, 2004 · Terminated
  ACT diff 2 Analyzer (Automated differential cell counter)