Automated Digital Morphology Analyzer DI-60 CC286297Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07350040972021), received between May 9, 2017 and Apr 16, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 reports).

2 other recalls cover devices cleared under the same FDA submission (K092868); 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2024Use of Device Problem; Use of Device Problem

  PRODUCT NAME: DI-60 UDI: (B)(4). SERIAL NUMBER: (B)(6). DATE OF MANUFACTURE: 2019-04 ACCESSORIES: N/A SW VER. NO.: CDMS 7.0.3 BUILD 18 REFERENCES: CUSTOMER COMPLAINT REPORT: (B)(4). COMPLAINT INVESTIGATION: (B)(4). VIGILANCE REPORTS: (B)(4). SUMMARY DESCRIPTION OF THE PROBLEM ON MARCH 18TH, 2024, CELLAVISION AB RECEIVED AN E-MAIL FROM SYSMEX AMERICA INC. (SAI) REPORTING A COMPLAINT ABOUT A CELLAVISION AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER (DI-60). THE COMPLAINT ALLEGES THAT AN INCORRECT RESULT HAD BEEN REPORTED RESULTING IN A BONE MARROW ASPIRATION FOR ONE PATIENT. THE INCIDENT WAS TO BE REPORTED BY SAI AS AN ADVERSE EVENT. FURTHER INVESTIGATION OF THE COMPLAINT FOUND THE FOLLOWING: DATE OF EVENT(S): · PATIENT A: SEPTEMBER 10, 2023 · PATIENT B: FEBRUARY 3, 2024 PATIENT A: AGE: 71 SEX: FEMALE SAMPLE ID: (B)(6) AUER ROD MISCLASSIFICATION BY OPERATOR LIKELY LED TO ADDITIONAL BONE MARROW ASPIRATION TESTING. SUBSEQUENT TESTING FOUND "NEGATIVE WITH NO SIGNS OF LEUKEMIA." PATHOLOGIST REVIEW CONFIRMED NO AUER RODS PRESENT IN THE ORIGINAL SLIDE. PATIENT B: AGE: 26 SEX: FEMALE SAMPLE ID: (B)(6) AUER ROD MISCLASSIFICATION BY OPERATOR LIKELY LED TO REFERRAL TO ONCOLOGIST, ADDITIONAL CBC/D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114027 ↗
• InjuryMar 27, 2024Use of Device Problem; Use of Device Problem

  THE USER REPORTED THAT AUER RODS WERE REPORTED FROM THE DI-60 CELLAVISION IN ERROR. PER THE USER, AN OPERATOR SELECTED AN INCORRECT CELL CATEGORY. DUE TO THE ERRONEOUS RESULTS REPORTED, A PATIENT UNDERWENT AN UNNECESSARY BONE MARROW ASPIRATION. NO HARM WAS REPORTED DUE TO THE UNNECESSARY BONE MARROW PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989647 ↗
• InjuryFeb 19, 2024Use of Device Problem; Use of Device Problem

  ON JANUARY 23RD, 2024, CELLAVISION AB RECEIVED AN E-MAIL FROM SYSMEX AMERICA INC. (SAI) REPORTING A COMPLAINT ABOUT A CELLAVISION AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER (DI-60). THE COMPLAINT ALLEGES THAT THE DI-60 FAILED TO DETECT PLATELET (PLT) CLUMPS ON A SMEAR, LEADING TO AN UNNECESSARY PLATELET TRANSFUSION AND BONE MARROW PROCEDURE FOR THE PATIENT. THE INCIDENT WAS TO BE REPORTED BY SAI TO FDA AS AN ADVERSE EVENT BY 2024-02-03. ACCORDING TO THE COMPLAINT, THE INITIAL SAMPLE WAS ANALYZED ON (B)(6) 2023 IN A SYSMEX HEMATOLOGY ANALYZER (XN)(CELL COUNTER), WHICH DISPLAYED LOW PLT CONCENTRATION AND FLAGGED FOR THROMBOCYTOPENIA, PLT CLUMPS, AND PLT ABNORMAL DISTRIBUTION. THE LAB SUBSEQUENTLY EXAMINED THE BLOOD SAMPLE FOR THE PRESENCE OF CLOTS USING APPLICATOR STICKS, AND IT CONTAINED NO VISIBLE CLOTS. THEY PROCEEDED TO ANALYZE THE SLIDE IN THE DI-60 AND ESTIMATED THE PLT CONCENTRATION IN THE PLT TAB, BEFORE COMPARING IT TO THE RESULT FROM THE XN. SINCE BOTH THE XN AND THE DI-60 (BASED ON ESTIMATION IN THE RBC MONOLAYER) SHOWED LOW PLATELET LEVELS, THE LAB REPORTED THESE RESULTS TO THE LIS SYSTEM. THEY DID NOT PERFORM A VISUAL EXAMINATION UNDER A LIGHT MICROSCOPE TO VERIFY THE AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730423 ↗
• InjuryFeb 2, 2024Use of Device Problem; Use of Device Problem

  THE USER ALLEGED THE PATIENT RECEIVED SEVEN UNNECESSARY PLATELET (PLT) TRANSFUSIONS OVER SEVERAL DAYS AND ONE BONE MARROW PROCEDURE BASED ON PLT RESULTS REPORTED. NO HARM WAS REPORTED DUE TO THE UNNECESSARY TRANSFUSIONS AND BONE MARROW PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636644 ↗
• MalfunctionApr 21, 2022Use of Device Problem; Program or Algorithm Execution Problem; Use of Device Problem; Program or Algorithm Execution Problem

  (B)(6) HAS REPORTED AN ISSUE THAT OCCURRED ON THE (B)(6) 2021. IT WAS REPORTED TO CELLAVISION ON THE (B)(6), AND THE PRODUCT CARE MEETING DECIDED TO OPEN A COMPLAINT INVESTIGATION ON THE 14TH OF DECEMBER. CELLAVISION DID HOWEVER NOT RECEIVE COMPLETE LOG FILES UNTIL THE 2ND OF FEBRUARY, WHICH ENABLED IN-DEPTH INVESTIGATION OF THE EVENT. IN CUSTOMER COMPLAINT (B)(4), (B)(6) REPORTS THAT A CUSTOMER EXPERIENCED AN ISSUE WHERE THE ANALYSIS OF ONE SLIDE INCORRECTLY BECAME ASSOCIATED WITH ANOTHER SLIDE. THIS MIX-UP OCCURRED AFTER THE CDMS SOFTWARE ON DI-60 HAD CRASHED, AND LATER THE FEEDER UNIT, CF-60 HAD WARNED OF AN ERROR. ACCORDING TO THE LOGS AND THE (B)(6) SERVICE REPORT THE FOLLOWING OCCURRED ON THE (B)(6): 06:00:58 ANALYSIS OF THE SLIDE WITH ORDER (B)(6) BEGINS. 06:02:33 CDMS CRASHES. NO CRASH DUMP IS GENERATED. 06:03:48 CDMS IS RESTARTED. 06:04:19 ANALYSIS OF THE SLIDE WITH ORDER (B)(6) BEGINS. SHORTLY THEREAFTER THE CF-60 BEGAN SIGNALING THAT AN ERROR HAS OCCURRED. AT AROUND 06:07 A TECH OPENS THE SLIDE AND NOTICES THAT THE CELLS ASSOCIATED WITH (B)(6) IN THE CDMS SOFTWARE WERE 70% LYMPHOCYTES AND 15% BLASTS WHILE THE CELL COUNTER COUNTED 15% LYMPHOCYTES AND HAD NO INDICATION OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165179 ↗
• MalfunctionFeb 18, 2022Use of Device Problem; Use of Device Problem

  THE USER REPORTED A SLIDE WITH SAMPLE ID (B)(6) WAS BEING PROCESSED BY THE DI-60 WHEN THE SYSMEX SLIDE CONVEYOR SHUTTLE, CF-60 CONNECTION UNIT, GENERATED AN ERROR. THE USER CLEARED THE ERROR AND REMOVED SLIDES FROM THE CF-60, BUT ONE SLIDE REMAINED IN THE GRIPPER OF THE DI-60. THE SYSTEM RESUMED OPERATION WITH THE PROCESSING OF THE SUBSEQUENT SLIDE, SAMPLE ID (B)(6). UPON RESULT REVIEW, THE USER RECOGNIZED A DISCREPANCY BETWEEN THE DI-60 CELL IMAGING RESULTS AND XN-10 CELL COUNTER ANALYSIS RESULTS. FURTHER INVESTIGATION BY THE USER DETERMINED DI-60 RESULTS FROM SAMPLE ID (B)(6) WERE INCORRECTLY ASSOCIATED WITH SAMPLE ID (B)(6). NO ERRONEOUS RESULTS WERE REPORTED. NO PATIENT HARM OCCURRED DUE TO THE EVENT. THE EVENT WAS ESCALATED TO CELLAVISION, THE MANUFACTURER OF THE DI-60, FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563855 ↗
• MalfunctionMay 9, 2017Display or Visual Feedback Problem; Patient Data Problem; Display or Visual Feedback Problem; Patient Data Problem

  SYSMEX HAS REPORTED A POTENTIAL ISSUE FOR THE DI-60 WHICH WAS DISCOVERED BY THEIR CLINICAL APPLICATIONS TEAM DURING AN INSTALLATION AT A CUSTOMER SITE IN THE US. IF A CUSTOMER FIRST PROCESSES A SLIDE (HENCEFORTH KNOWN AS SLIDE 1) WITH AN UNREADABLE BARCODE, AND THEN AFTERWARDS PROCESS A SLIDE WITH A BARCODE STARTING WITH ERR (HENCEFORTH KNOWN AS SLIDE 2), THEN THE IMAGE OF THE BARCODE OF SLIDE 1 WILL BE VISIBLE IN THE PATIENT INFORMATION DIALOG OF SLIDE 2 (BUG #8093). THIS WILL GIVE THE FALSE IMPRESSION THAT THE DI-60 BARCODE READER COULD NOT READ THE BARCODE OF SLIDE 2. IF THE USER IS NOT CAREFUL, THERE IS A RISK THAT THE USER ASSIGNS AN INCORRECT ORDER ID (THE ORDER ID BELONGING TO THE FIRST SLIDE) TO THE SECOND SLIDE. IF A USER TRIES TO ASSIGN SLIDE 2 THE SAME ORDER ID SLIDE 1 BEFORE THE SLIDE 1 HAS BEEN SIGNED, THE USER WILL GET AN ERROR MESSAGE, INFORMING THE CUSTOMER THAT THE ORDER ID ALREADY EXISTS. IF SLIDE 1 HAS ALREADY BEEN SIGNED, IT IS POSSIBLE TO GIVE SLIDE 2 THE SAME ORDER ID AS SLIDE 1. IN THAT CASE IT IS LIKELY THAT THE LIS WILL ALERT THE CUSTOMER THAT AN ERROR HAS BEEN MADE, SINCE THE LIS THEN RECEIVES TWO SETS OF RESULTS FOR THE FIRST SLIDE AND NONE FOR THE SECOND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6553709 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092868. One submission often covers many models, so check the product and lot details in each record.

• Z-0542-2026 · Oct 8, 2025 · Open, Classified
  REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
• Z-2184-2018 · Dec 4, 2017 · Open, Classified
  CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locat