UniCel DxH 800 (REF 629029, B66445)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 15099590381646), received between Oct 17, 2016 and Apr 5, 2024 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Output Problem” (15 reports).

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

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 16, 2026.

Recalls naming this device

1. Aug 13, 2025Open, Classified

   Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

   Z-2574-2025 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INCORRECT RESULT / FALSE H & H CRITICAL RESULT FLAGGED /WBC /RBC /HGB/HCT/ MCH/MCHC / PLATELETS HIGHER // ON ONE SAMPLE. THERE WERE INDICATIONS OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY, LEADING TO ONE PATIENT RECEIVING ONE UNIT OF BLOOD. THE ERRONEOUS RESULTS WERE NOT CONFIRMED BY THAT LABORATORY AND IT IS UNKNOWN IF THAT TRANSFUSION WAS REQUIRED. NO PATIENT HISTORY WAS AVAILABLE. THERE WAS NEITHER DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO SUFFICIENT EVIDENCE THAT REASONABLY SUGGESTS A MALFUNCTION. BASED ON THE SERVICEMAX SERVICE REQUEST CA-06603370 DATED MARCH-09-2024, THE CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER'S REPORTED ISSUE. THE CTS CONFIRMED THIS ISSUE WAS ISOLATED TO ONE PATIENT SAMPLE. THE REPORTED ISSUE COULD NOT BE REPRODUCED BY THE CTS, AND NO INSTRUMENT MALFUNCTION WAS IDENTIFIED. THE CUSTOMER AGREED WITH THE SOLUTION AND DID NOT CALL BACK TO REPORT ANY ISSUES. SERVICE RECORDS FOR THE INSTRUMENT HAVE BEEN REVIEWED AND THERE IS NO REPORT OF A RECURRENCE OF THIS EVENT BY THE CUSTOMER. SYSTEM WAS VERIFIED TO MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE SYSTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050981 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED APPROXIMATELY FIVE PATIENT SAMPLES RECOVERED WITH HIGH RBC AND PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH800 INSTRUMENT COMPARED TO ALTERNATE INSTRUMENT. MEAN CORPUSCULAR VOLUME (MCV) RESULTS WERE ALSO DISCORDANT BETWEEN INSTRUMENTS. NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PRINTOUTS OF THE EVENT REQUESTED BUT NOT PROVIDED. PLATELET AND RBC SUSPECT MESSAGING COULD NOT BE VERIFIED. MANUAL SMEAR RESULTS WERE REQUESTED BUT WAS NOT AVAILABLE FOR REVIEW. THE CUSTOMER PERFORMED AN APERTURE CLEANING. HOWEVER, THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389977 ↗
• MalfunctionApr 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THROMBOCYTOPENIC PATIENT SAMPLES RECOVERED WITH HIGHER PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH 800 HEMATOLOGY INSTRUMENT (DXH800-3) COMPARED TO ALTERNATE DXH800 INSTRUMENTS. 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. PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 1) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. NO SUSPECT MESSAGING ON EITHER RUN. PRINTOUTS ALSO RECEIVED INDICATED TWO PATIENT SAMPLES (SAMPLE 2 AND SAMPLE 3) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO RERUNS ON ALTERNATE INSTRUMENTS THE CUSTOMER BELIEVES TO BE CORRECT. IT IS UNKNOWN IF EITHER RUN RECOVERED WITH SUSPECT MESSAGING. THE NEXT SET OF PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 4) RECOVERED WITH HIGHER PLATELET RESULTS FROM THE DXH800-3 COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. BOTH RUNS RECOVERED WITH SUSPECT MESSAGING. THE LAST PRINTOUTS RECEIVED (SAMPLE 5) RECOVERED WITH HIG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186889 ↗
• MalfunctionSep 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INITIALLY REPORTED RECOVERING LOW HEMOGLOBIN (HGB) RESULTS ON QC SAMPLES ALONG WITH ERRONEOUS HIGH MEAN CORPUSCULAR VOLUME (MCV), RED CELL DISTRIBUTION WIDTH (RDW) AND PLATELET (PLT) RESULTS WHEN RUN ON THEIR DXH 800 INSTRUMENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435260 ↗
• InjuryAug 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE DXH800 INSTRUMENT GENERATED ERRONEOUS HIGH MCHC AND ERRONEOUS HEMOGLOBIN(HGB) RESULTS ON PATIENT SAMPLES. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2021, A BEC APPLICATIONS SPECIALIST VISITED THE SITE AND WAS INFORMED THAT PATIENT CARE FOR 3 PATIENTS HAD BEEN AFFECTED BY THE REPORTED EVENT. TWO PATIENTS RECEIVED UNNECESSARY TRANSFUSIONS AND ONE PATIENT WHERE HGB RESULTS WERE OVERESTIMATED DID NOT RECEIVE A NEEDED TRANSFUSION. PER THE CUSTOMER THERE WAS NO CLINICAL IMPACT THAT RESULTED FROM THE TWO UNNECESSARY TRANSFUSIONS OR THE ONE DELAYED TRANSFUSION. PER CUSTOMER COMMUNICATION ON 05-JULY-2021, THE CUSTOMER CONFIRMED THAT A PATIENT RECEIVED AN UNNECESSARY TRANSFUSION BASED ON ERRONEOUS LOW HGB RESULTS.

  Patient problems: Unspecified Blood or Lymphatic problem

  MAUDE report 12278587 ↗
• MalfunctionAug 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THEIR DXH800 INSTRUMENT GAVE AN ERRONEOUS ELEVATED PLATELET (PLT) RESULT FOR ONE SPECIFIC PATIENT COMPARED TO SAME SAMPLE RERUN, MANUAL ESTIMATE AND DELTA CHECK. THE CUSTOMER TECHNICAL SUPPORT (CTS) CONFIRMED ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB, NO OTHER SAMPLES WERE IMPACTED, AND QC WAS WITHIN SPECIFICATION AT TIME OF EVENT. 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 12278586 ↗
• MalfunctionAug 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ERRONEOUSLY HIGH PLATELET (PLT) RESULTS WERE GENERATED FOR THREE PATIENT SAMPLES ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. TWO PATIENT RESULTS WERE FLAGGED, ONE WAS UNFLAGGED. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY, AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10421041 ↗
• MalfunctionJun 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELETS (PLT) RESULTS ON ONE PATIENT SAMPLE ON THEIR DXH800 INSTRUMENT COMPARED WITH MANUAL SMEAR RESULTS. MANUAL RESULTS WERE ACCEPTED AS CORRECT AND REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156101 ↗
• MalfunctionJun 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELETS (PLT) RESULTS ON ONE PATIENT SAMPLE ON THEIR DXH800 INSTRUMENT COMPARED WITH MANUAL SMEAR RESULTS. MANUAL RESULTS WERE ACCEPTED AS CORRECT AND REPORTED TO THE PHYSICIAN. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156099 ↗
• InjuryMar 3, 2020Output Problem; Output Problem

  THE CUSTOMER REPORTED A SPECIFIC PATIENT RUN ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GAVE A LOW HEMOGLOBIN (HGB)=88 AND WHITE BLOOD CELL (WBC)=3.7 RESULT. THE PATIENT WAS TRANSFUSED WITH 1 UNIT (BLOOD). A SAMPLE WAS RUN POST TRANSFUSION THE NEXT DAY WITH HIGHER THAN EXPECTED HGB AT 152. THE ORIGINAL SAMPLE WAS RERUN TWO DAYS AFTER INITIAL RUN WITH HIGHER HGB RESULTS OF 155 AND 154 ON BOTH DXH INSTRUMENTS. THERE WAS NO DEATH OR LIFE-THREATENING INJURY ASSOCIATED WITH THIS INCIDENT. A PATIENT WAS TRANSFUSED WITH 1 UNIT OF BLOOD DUE TO CLINICIAN¿S ASSESSMENT OF PATIENT¿S REPORTED COMPLAINT OF EPIGASTRIC PAIN AND LOW HGB RECOVERY. THERE WAS NO INFORMATION INDICATING THE BLOOD TRANSFUSION CAUSED ANY ADDITIONAL CHANGE IN PATIENT TREATMENT.

  Patient problems: Test Result

  MAUDE report 9783200 ↗
• MalfunctionFeb 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT A SPECIFIC PATIENT SAMPLE RUN ON THEIR DXH800 INSTRUMENT GAVE A HIGH PLATELET (PLT) RESULT COMPARED TO RERUN OF THE SAME SPECIMEN AND A SLIDE REVIEW. THE CUSTOMER TECHNICAL SPECIALIST (CTS) DOCUMENTED THAT THE INITIAL SAMPLE WAS RUN ON (B)(6) 2020 AT 19:42, WITH A NON-CREDIBLE PLT RESULT (1098). THE CUSTOMER RERAN THE SAME SPECIMEN AT 23:21, WITH A PLT RESULT OF 260, A SLIDE REVIEW WAS ALSO PERFORMED TO CONFIRMED THE SECOND RUN (PLT=260). INSTRUMENT PRINTOUTS WERE REQUESTED BUT NOT PROVIDED FOR THIS EVENT, INSTRUMENT FLAGGING, IF PRESENT COULD NOT BE DETERMINED. THERE WAS NO REPORT OF DEATH OR INJURY ASSOCIATED WITH THIS INCIDENT. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9709332 ↗
• MalfunctionSep 4, 2019High Test Results

  THE CUSTOMER REPORTED THAT THEY HAD DRAWN TWO SAMPLES FROM ONE PATIENT. ONE OF THE TWO SAMPLES GENERATED THE EXPECTED PLATELET (PLT) BASED ON THE PATIENT'S MEDICAL HISTORY. THE SECOND SAMPLE GENERATED AN ERRONEOUSLY HIGH PLATELET RESULT. BOTH SAMPLES WERE RUN ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO DEATH OR INJURY ATTRIBUTED TO OR CONNECTED WITH THIS EVENT THERE WAS NO CHANGE IN PATIENT TREATMENT. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, TO THE FLOOR NURSE, WHO DETECTED THE INCONSISTENCY. THE NURSE CALLED THE LAB TO ALERT THEM ABOUT THE RESULTS NOT MATCHING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8960494 ↗
• MalfunctionAug 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PLATELET (PLT) QUALITY CONTROL (QC) OUT VERY HIGH ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862258 ↗
• MalfunctionJun 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PLATELET FAILING HIGH ON CONTROLS AND PATIENTS ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725017 ↗
• MalfunctionSep 28, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT PLATELET (PLT) RESULTS FOR PATIENTS SAMPLES ARE RUNNING ERRONEOUSLY HIGH ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO CHANGE TO PATIENT TREATMENT REPORTED AS A RESULT OF THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA.

  Patient problems: Test Result

  MAUDE report 7920641 ↗
• MalfunctionSep 28, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON THREE PATIENT SAMPLES. THE RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT RELATED TO THIS EVENT. REVIEW OF THE PRINT OUTS PROVIDED BY THE CUSTOMER SHOW THAT TWO PATIENTS RUN ON (B)(6) 2018 GAVE ABNORMALLY HIGH PLT VALUES AT 7:13 AND 7:15 WITH NO SYSTEM FLAGS OR MESSAGES. ANOTHER PATIENT RUN THAT DAY AT 7:21 GAVE AN ERRONEOUS HIGH PLT RESULT OF 506, HOWEVER, THE INSTRUMENT GENERATED R FLAGS FOR PLT AND PLT INTER: DEBRIS SYSTEM MESSAGES FOR THIS RUN. THE CUSTOMER RERAN THE ABNORMALLY HIGH PLT SAMPLES AND VERIFIED THE RESULTS WERE ERRONEOUS.

  Patient problems: Test Result

  MAUDE report 7920150 ↗
• InjurySep 28, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED RECOVERING DISCREPANT CBC RESULTS ON A SINGLE PATIENT SAMPLE RUN ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (DXH8001). THE CUSTOMER STATED THE PATIENT¿S SAMPLE WAS RUN ON TWO OF THE LAB¿S DXH 800 INSTRUMENTS; THE RESULTS WERE CONSIDERED ERRONEOUS WHEN THE RESULTS FROM THE DXH 8002 INSTRUMENT DID NOT MATCH THE RESULTS GENERATED BY THE DXH 8001 INSTRUMENT. INSTRUMENT PRINTOUTS PROVIDED FOR REVIEW CONFIRMED ON (B)(6) 2018, DISCREPANT CBC RESULTS WERE RECOVERED ON THE DXH8002 INSTRUMENT, IN PARTICULAR LOWER WBC, RBC, HGB, HCT, AND MCHC WITH NO INSTRUMENT SUSPECT MESSAGES WHEN COMPARED TO THE RESULTS RECOVERED ON THE DXH 8001 INSTRUMENT. PER TELEPHONE CONVERSATION WITH THE CUSTOMER ON (B)(6) 2018, THE CUSTOMER CONFIRMED THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND THE PATIENT TRANSFUSED BASED ON THE INITIAL HGB-5.3 AND HCT-18.7 RESULTS. A MANUAL SLIDE REVIEW OF THE PATIENT¿S SAMPLE WAS NOT PERFORMED. ALL CONTROLS RECOVERED WITHIN SPECIFICATION.

  Patient problems: Test Result

  MAUDE report 7918811 ↗
• InjurySep 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM DID NOT GENERATE DIFFERENTIAL ABNORMAL CELL FLAGS FOR A (B)(6) FEMALE PATIENT WITH MULTIPLE MYELOMA (MM). THE CUSTOMER INDICATED THAT ONE OF THEIR PATIENTS, WHOM LATER ON WAS DIAGNOSED WITH MULTIPLE MYELOMA, DID NOT RECEIVE TIMELY AND ADEQUATE TREATMENT, DUE TO THE ABSENCE OF FLAGGING, FOR CELL POPULATIONS ASSOCIATED WITH MULTIPLE MYELOMA. THE FIRST CONTACT WITH THE CLINIC OCCURRED ON (B)(6) 2018, WITH A SECOND VISIT ON (B)(6) 2018. BY THE TIME OF THE SECOND VISIT, THE LAB WAS AWARE OF A POTENTIAL CONDITION WITH THE PATIENT, WHEN A BONE MARROW ANALYSIS WAS ORDERED UNDER THE SUSPICION OF MULTIPLE MYELOMA. THE SAME DAY THE PATIENT HAD ANOTHER CBC+DIFF (DIFFERENTIAL) REQUEST, BUT WAS STOPPED BY THE RULES ON THE LABORATORY INFORMATION SYSTEM (LIS) FOR DELTA CHECK ON HEMOGLOBIN (HGB). FOLLOWING THIS EVENT, THEY PERFORMED A SLIDE REVIEW FOR SUSPECTED MACROCYTIC ANEMIA, AND OBSERVED 10% ATYPICAL PLASMA CELLS. MOREOVER, AN ELECTROPHORESIS DONE THE SAME DAY, GENERATED A CONCENTRATION OF 50 G / L IN THE GAMMA AREA. THE DIAGNOSIS WAS EFFECTIVELY CONFIRMED THROUGH ELECTROPHORESIS AND BONE MARROW ANALYSIS PRINTOUTS

  Patient problems: Test Result

  MAUDE report 7895813 ↗
• MalfunctionAug 24, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR 510K UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED VOTE OUTS ON WBC/DIFFERENTIALS AND PLATELETS (PLT). DAILY CHECKS HAD FAILED, THEN PASSED AFTER FURTHER TROUBLESHOOTING. PATIENT SAMPLES WERE RERUN TO VERIFY INSTRUMENT OPERATION FOLLOWING TROUBLESHOOTING. PLT RESULTS WERE NOT MATCHING EARLIER PLT RESULTS ON TWO (2) PATIENTS. RESULTS FROM TWO PATIENTS ((B)(6)) WERE PROVIDED. INITIAL RUN ON EACH SAMPLE SHOWED LOWER PLT RESULT COMPARED TO THE SAME SAMPLE RERUN SEVERAL HOURS LATER FOLLOWING TROUBLESHOOTING. NO FLAGS PRESENT FOR EITHER RUN. HOWEVER, FURTHER REVIEW SHOWED EACH SAMPLE DISPLAYED INDIVIDUAL APERTURE VOTE OUT ON THE RERUN POSSIBLY INDICATING RESTRICTED APERTURE FLOW. MANUAL SLIDE ESTIMATE FOR PATIENT (B)(6)CORRELATED WITH THE INITIAL, LOWER PLT RESULT. MANUAL PLT ESTIMATE WAS NOT PROVIDED FOR PATIENT (B)(6). NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO INJURY, NO EXPOSURE AND NO HARM TO PATIENT OR USER ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Test Result

  MAUDE report 7815408 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED HIGH PLATELET (PLT) AND LOW WHITE BLOOD CELL (WBC) RESULTS WERE GENERATED ON PATIENT SAMPLES ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. IT IS UNKNOWN IF THERE WERE ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THE CUSTOMER RE-RAN SAMPLES ON ANOTHER INSTRUMENT TO IDENTIFY THE PROBLEM. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT.

  Patient problems: Test Result

  MAUDE report 7728971 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED INCONSISTENT PLATELET (PLT) RESULTS BEING GENERATED BY THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT FROM THE INFORMATION PROVIDED. INSTRUMENT PRINTOUTS OF PATIENT RESULTS OR CONTROLS WERE NOT PROVIDED FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7726931 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER STATED THE PLATELET (PLT) RESULTS WERE NOT MATCHING ON RERUNS. 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 7726824 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THE PLATELET (PLT) RESULTS FOR PATIENT SAMPLES ON ONE OF THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM ARE NOT MATCHING THEIR OTHER TWO DXH INSTRUMENTS. 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 7726814 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT PLATELET (PLT) RESULTS ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WERE NOT CORRELATING. 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 7726769 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT PLATELET (PLT) RESULTS WERE NOT CORRELATING ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. 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 7726748 ↗