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DxH 900 Hematology System C11478Recalls & reported problems

Beckman Coulter, Inc. · DxH 900 Hematology Analyzer, DxH 900 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
17
Deaths reported
0
Injuries reported
7
Recalls naming it
1

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 15099590701574), received between Jun 25, 2019 and Jan 27, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (8 reports).

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

18 other recalls cover devices cleared under the same FDA submission (K140911, K240252); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 13, 2025Class IIOpen, 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-2572-2025 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings8
  • Output Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Arcing1
  • Defective Component1
  • Fire1
  • High Test Results1
  • Improper or Incorrect Procedure or Method1

Patient problems

  • No Clinical Signs, Symptoms or Conditions15
  • Cancer1
  • Injury1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 27, 2026Output Problem

    THE CUSTOMER REPORTED THEIR DXH 900 HEMATOLOGY INSTRUMENT (PART C11478, SERIAL NUMBER (B)(6) GENERATED AN ERRONEOUS HEMOGLOBIN (HGB) RESULT OF 4.2 G/DL FROM A SUSPECTED CONTAMINATED SAMPLE INSTEAD OF THE CORRECT VALUE OF APPROXIMATELY 12 G/DL LEADING TO THE PATIENT RECEIVING AN UNNECESSARY BLOOD TRANSFUSION. ALL COMPLETE BLOOD COUNT (CBC) PARAMETERS WERE FOUND TO BE ERRONEOUS. IT WAS CONFIRMED THAT THE ADMIMISTRATION OF THE TRANSFUSION DID NOT HAVE AN ADVERSE IMPACT ON THE PATIENT. THE CUSTOMER REPORTED THAT DURING THE COLLECTION OF THE SAMPLE, IT WAS SUSPECTED OF BEING CONTAMINATED AND THEY DID NOT SUSPECT INSTRUMENT MALFUNCTION. PATIENT DATA WAS PROVIDED FOR REVIEW. ALL CBC PARAMETER RESULTS, [WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMATOCRIT (HCT), MEAN CORPUSCULAR VOLUME (MCV), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC), MEAN CORPUSCULAR HEMOGLOBIN (MCH), RED CELL DISTRIBUTION WIDTH (RDW), PLATELET (PLT) AND MEAN PLATELET VOLUME (MPV)], GENERATED FROM THE SUSPECTED CONTAMINATED SAMPLE WERE ERRONEOUS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24196290 ↗
  • InjuryOct 16, 2025Output Problem; Output Problem

    THE CUSTOMER REPORTED DISCREPANCIES IN THE WHITE BLOOD CELL (WBC) COUNTS AND NUCLEATED RED BLOOD CELL (NRBC) PERCENTAGES IN A NEWBORN'S TEST RESULTS ON THEIR DXH 900 HEMATOLOGY INSTRUMENT (PART NUMBER C1147, SERIAL NUMBER (B)(6)). ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AND THERE WAS A REPORTED IMPACT TO PATIENT TREATMENT. BECAUSE OF THE INACCURATE VALUES OF THE WHITE BLOOD CELLS (WBC), A PEDIATRIC PATIENT WAS PRESCRIBED ANTIBIOTICS THAT WERE NOT REQUIRED. THERE WAS NO REPORT OF AN ADVERSE IMPACT DUE TO THE UNNECESSARY MEDICATION. THE CUSTOMER STATED THAT THE INSTRUMENT REPORTED 148.8×10³/L WBC AND 114.6 NRBCS/100 WBCS. HOWEVER, THE MANUAL (REFERENCE) COUNT SHOWED A WBC OF 70×10³/L AND 164 NRBCS/100 WBCS. SAMPLES AND SYSTEM FLAGS WERE REVIEWED, AND THE INSTRUMENT WAS FOUND TO DISPLAY AN "MCV INTERFERENCE WBC" FLAG. IT WAS DISCUSSED WITH THE CUSTOMER THAT THIS FLAG INDICATES POSSIBLE INTERFERENCE AND ADVISES REVIEW OF THE RESULTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23319366 ↗
  • MalfunctionAug 6, 2025High Test Results; High Test Results

    THE CUSTOMER REPORTED THAT ONE PATIENT SAMPLE RECOVERED WITH ERRONEOUS HIGH PLATELET (PLT) RESULTS AND REVIEW [R] FLAGGING WHEN CYCLED ON THEIR DXH900 HEMATOLOGY INSTRUMENT (DXH900-3) COMPARED TO A RERUN OF THE SAMPLE ON THEIR OTHER DXH900 HEMATOLOGY INSTRUMENT (DXH900-4). NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF AN ADVERSE EVENT. THERE WAS NO REPORT OF DEATH, INJURY, DELAY OR CHANGE TO PATIENT TREATMENT OR DIAGNOSIS. THERE WAS NO REPORT OF HARM TO PATIENT OR OPERATOR. PRINTOUTS OF THE EVENT PROVIDED. PRINTOUTS RECEIVED INDICATED ONE PATIENT SAMPLE (SAMPLE 1) RECOVERED WITH A HIGH PLT AND MEAN PLATELET VOLUME (MPV) RESULT AND SUSPECT MESSAGING COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT THE CUSTOMER BELIEVES TO BE CORRECT. ALL OTHER CBC RESULTS CORRELATED BETWEEN RUNS. ONSITE SERVICE GENERATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22734343 ↗
  • MalfunctionMar 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED AN ERROR ON ALL THREE OPENINGS OF THE RED BLOOD CELL (RBC) OF THEIR DXH900 INSTRUMENT. ERRONEOUS RESULTS WERE GENERATED FOR ALL PARAMETERS, INCLUDING ERRONEOUSLY HIGH PLATELET RESULTS, FOR PATIENT SAMPLES. 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. PATIENT DATA WAS REQUESTED BUT NOT PROVIDED. ONSITE SERVICE WAS SCHEDULED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21528861 ↗
  • MalfunctionAug 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THEIR DXH 900 INSTRUMENT GENERATED HIGH PLATELET (PLT) PARAMETER RESULTS FOR PATIENT SAMPLES. THE INSTRUMENT GENERATED INTERMITTENT R FLAGS AND SUSPECT MESSAGES. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RUN ON AN ALTERNATE INSTRUMENT TO OBTAIN THE CORRECT RESULTS. CUSTOMER DATA WAS PROVIDED FOR PATIENT SAMPLES REFLECTING ERRONEOUS HIGH PLT RESULTS ALONG WITH THE CORRECT RESULTS RUN ON AN ALTERNATE INSTRUMENT. THE MANUAL SLIDE REVIEW PROVIDED FOR TWO SAMPLES AGREES WITH THE LOWER RESULT FROM THE ALTERNATE INSTRUMENT. R FLAGS AND SUSPECT MESSAGES WERE INTERMITTENT. NOT ALL ERRONEOUS PLT RESULTS WERE FLAGGED BY THE INSTRUMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17647723 ↗
  • InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16905809 ↗
  • MalfunctionApr 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED, THREE PATIENT SAMPLES RECOVERED WITH HIGH PLATELET (PLT) RESULTS WHEN CYCLED ON THEIR DXH900 INSTRUMENT. TWO PATIENT SAMPLES RECOVERED WITH SUSPECT MESSAGING. ONE PATIENT SAMPLE DID NOT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PRINTOUTS RECEIVED, INDICATED ONE PATIENT SAMPLE (SAMPLE 1) RECOVERED WITH LOW WBC, RBC, HEMATOCRIT (HCT) AND HIGH PLATELET (PLT) RESULTS, COMPARED TO A REDRAWN SAMPLE TWO DAYS LATER THE CUSTOMER BELIEVES TO BE CORRECT. PRINTOUTS ALSO RECEIVED, INDICATED A SECOND PATIENT SAMPLE (SAMPLE 2) RECOVERED WITH LOW WBC, RBC, HEMOGLOBIN (HGB) AND HCT RESULTS ALONG WITH HIGH MEAN CORPUSCULAR HEMOGLOBIN (MCH). MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) AND PLT RESULTS WITH SUSPECT MESSAGING COMPARED TO A REDRAWN SAMPLE TWO DAYS LATER THE CUSTOMER BELIEVES TO BE CORRECT. THE LAST PRINTOUTS RECEIVED, INDICATED A THIRD PATIENT SAMPLE (SAMPLE 3) RECOVERED WITH LOW WBC, RBC, HCT RESULTS ALONG WITH HIGH MCH, MCHC AND PLT RESULTS, AND SUSPECT MESSAGING COMPARED TO A REDRAWN SAMPLE TWO DAYS LATER THE CUSTOMER BELIEVES TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16773277 ↗
  • MalfunctionJan 26, 2023Arcing; Arcing

    THE CUSTOMER REPORTED THERE WAS A LEAK AT THE WASTE DRAIN WHICH CAUSED THE POWER PLUG OF THE DXH900 HEMATOLOGY INSTRUMENT TO SPARK AND GENERATE SMOKE. THE DXH900 INSTRUMENT GENERATED THE SPARK AND SMOKE WHEN AN EXTENSION CORD CONNECTED TO THE INSTRUMENT CAME IN CONTACT WITH A LEAK. A FIRE EXTINGUISHER WAS USED BY THE OPERATORS AS A PREVENTIVE MEASURE AND THE FIRE DEPARTMENT WAS CALLED AS REQUIRED BY LABORATORY PROTOCOL. THERE WAS NO REPORT OF A VISIBLE FLAME. IT WAS CONFIRMED THAT THE ONLY COMPONENT THAT WAS BURNT WAS THE CABLE CONNECTION BETWEEN THE INSTRUMENT SPM (SPECIMEN TRANSPORT MODULE) AND THE EXTENSION CORD GOING TO THE UPS. THERE WAS NO OTHER DAMAGE TO THE LABORATORY AS A RESULT OF THIS EVENT. THERE AS ONE OPERATOR THAT COMPLAINED OF A SORE THROAT BUT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR NEED TIME OFF FROM WORK. 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 16251114 ↗
  • MalfunctionOct 28, 2022Fire; Fire

    THE CUSTOMER REPORTED THE UPS FOR THE DXH900 HEMATOLOGY INSTRUMENT SHORTED AND CAUGHT FIRE. THE CUSTOMER USED THE LABORATORY FIRE EXTINGUISHER TO CONTAIN THE FLAMES, FIREFIGHTERS WERE CALLED BUT THE FIRE HAD ALREADY BEEN EXTINGUISHED, THEY ADVISED THE CUSTOMER NOT TO USE THE UPS. THE UPS WAS TURNED OFF AND THE EQUIPMENT POWER CABLES DISCONNECTED. THERE WAS NO REPORT OF INJURY OR EXPOSURE AS A RESULT FO THIS EVENT. PATIENT RESULTS WERE NO IMPACTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15688267 ↗
  • MalfunctionDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED GETTING DASHES ON RED BLOOD CELL (RBC), RBC PARAMETERS AND PLATELET (PLT) ON THEIR DXH 900 HEMATOLOGY INSTRUMENT. THE INSTRUMENT WAS ALSO GENERATING 'CHECK FOR CLOTS' ERRORS FOR PLT. THE CUSTOMER ALSO REPORTED ERRONEOUSLY HIGH PLT RESULTS FOR TWO PATIENTS. PATIENT DATA WAS REQUESTED BUT THE CUSTOMER WAS UNABLE TO PROVIDE IT BECAUSE THEY DID HAD NOT SEPARATED THEM AND DID NOT HAVE TIME TO SEEK THEM OUT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. 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 13006975 ↗
  • InjuryDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED ONE PATIENT SAMPLE WITH MULTIPLE MYELOMA RECOVERED WITH A HIGH PLATELET (PLT) COUNT AND NO PLATELET SPECIFIC SUSPECT MESSAGING WHEN CYCLED ON THE DXH900 HEMATOLOGY INSTRUMENT COMPARED TO A RERUN ON A DIFFERENT INSTRUMENT AND MANUAL SLIDE REVIEW. THE HIGHER PLATELET REPORT WAS SENT TO THE PHYSICIAN CAUSING A DELAY IN A PLATELET INFUSION PROCEDURE FOR THE PATIENT. A CORRECTED REPORT WAS SENT.

    Patient problems: Cancer

    MAUDE report 12996313 ↗
  • MalfunctionNov 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 900 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS FOR ONE PATIENT SAMPLE COMPARED TO A RERUN ON ANOTHER INSTRUMENT. INITIAL PLT RESULT FOR THE PATIENT - 27.4. RERUN RESULTS - 23.53. THE 23.53 WAS CONSIDERED CORRECT AND REPORTED OUT OF THE LABORATORY. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF SERIOUS INJURY OR IMPACT TO PATIENT TREATMENT RELATED TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12776646 ↗
  • MalfunctionNov 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED THAT THEIR DXH 900 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES. THERE WAS NO INDICATION OF ERRONEOUS RESULTS BEING REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE OR EFFECT ON PATIENT TREATMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12755556 ↗
  • InjuryFeb 10, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    THE CUSTOMER REPORTED ONE PATIENT SAMPLE RUN ON THE DXH900 HEMATOLOGY INSTRUMENT RECOVERED WITH ERRONEOUS LOW NEUTROPHIL AND HIGH MONOCYTE RESULT WITH SUSPECT MESSAGING COMPARED TO A MANUAL SLIDE REVIEW. THE PATIENT WAS ADMINISTERED AN UNNECESSARY CEREBRAL SPINAL FLUID (CSF) PROCEDURE DUE TO THE EVENT. THE REPORT WAS CORRECTED AFTER THE PROCEDURE WAS COMPLETED. THERE WAS NO DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11311994 ↗
  • MalfunctionDec 16, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER REPORTED ERRONEOUSLY HIGH, UNFLAGGED PLATELET (PLT)RESULTS FOR ONE PATIENT ON THEIR UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM. THE PATIENT WAS A BURN VICTIM AND THE CUSTOMER STATED THE HIGH PLT RESULT OCCURRED BECAUSE OF THE FRAGMENTED ERYTHROCYTE IN THE PATIENT SAMPLE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB, THE CUSTOMER PERFORMED A MANUAL SMEAR. THE CUSTOMER INDICATED THAT THE NUMERIC RESULT FROM THE DXH 900 INSTRUMENT WAS 349 x 10^3/UL , HOWEVER, THE RESULTS FOR THE MANUAL SLIDE REVIEW YIELDED 217 x 10^3/UL. THE COUNT OBTAINED THROUGH THE MANUAL SLIDE REVIEW WAS THE COUNT USED FOR CLINICAL REPORTING. 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 11018654 ↗
  • InjuryDec 8, 2020Defective Component; Defective Component

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) PUNCTURED HIS FINGER ON THE PIERCING PROBE OF A CUSTOMER'S UNICEL DXH 900 COULTER CELLULAR ANALYSIS SYSTEM WHILE SERVICING IT. THE FSE WENT TO THE CUSTOMER LAB SITE FOR A LEAKY DXH900 ASPIRATION PROBE. WHILE ADDRESSING THE LEAK, THE FSE PLACED A PAPER TOWEL UNDERNEATH THE ASPIRATION PROBE WHILE IT WAS IN MOTION. THE FSE STATED HE HAD DONE THIS PROCEDURE BEFORE AND THOUGHT HE HAD A FEW MORE SECONDS, THE PROBE EXTENDED AND PIERCED HIS LEFT INDEX FINGER. THE FSE WENT TO THE EMERGENCY ROOM WHERE BLOOD WAS DRAWN TO SCREEN FOR (B)(6). BASELINE TESTING WAS PERFORMED; THE FIRST BLOOD RESULTS CAME BACK B)(6). THE FSE WILL BE SCHEDULING TWO FOLLOW UP APPOINTMENTS AT 6 WEEKS AND 6 MONTHS FOR HIS SECOND AND THIRD ROUND OF (B)(6) SHOTS. THE FSE REPORTED HE IS HEALTHY AND ABLE TO CONTINUE WITH WORK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10973328 ↗
  • InjuryJun 25, 2019Installation-Related Problem; Installation-Related Problem

    IN THE PROCESS OF INSTALLING THE DXH 900 HEMATOLOGY INSTRUMENT AT THE CUSTOMER SITE, THE FIELD SERVICE ENGINEER (FSE) INJURED THE INDEX FINGER ON HIS LEFT HAND WHEN A FLAP IN THE REAR AREA OF THE INSTRUMENT OPENED JERKILY. THE FSE WAS TREATED BY A DOCTOR. THE HAND WAS X-RAYED AND THE FINGER WAS FOUND TO BE BRUISED AND FRACTURED. THE INJURY DID NOT REQUIRE STITCHES BUT THE FINGER WAS STABILIZED WITH A RAIL/SPLINT.

    Patient problems: Injury

    MAUDE report 8730463 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140911, K240252. One submission often covers many models, so check the product and lot details in each record.

  • Z-2573-2025 · Aug 13, 2025 · Open, Classified
    UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
  • Z-0516-2020 · Oct 7, 2019 · Terminated
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully aut
  • Z-1384-2019 · Jul 30, 2018 · Terminated
    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is curre
  • Z-1382-2019 · Jul 30, 2018 · Terminated
    UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative mu
  • Z-1383-2019 · Jul 30, 2018 · Terminated
    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except
  • Z-0236-2018 · Nov 3, 2017 · Terminated
    UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
  • Z-0237-2018 · Nov 3, 2017 · Terminated
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument c
  • Z-0238-2018 · Nov 3, 2017 · Terminated
    UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
  • Z-3101-2017 · Jun 20, 2017 · Terminated
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodolog
  • Z-2158-2017 · Apr 24, 2017 · Terminated
    UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
  • Z-2157-2017 · Apr 24, 2017 · Terminated
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
  • Z-1013-2017 · Dec 19, 2016 · Terminated
    UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
  • Z-1014-2017 · Dec 19, 2016 · Terminated
    DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
  • Z-2732-2016 · Aug 8, 2016 · Terminated
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unic
  • Z-2692-2016 · Aug 4, 2016 · Terminated
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH

…and 3 more.

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