CELL-DYN 04R1301Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380740136093), received between Oct 6, 2021 and May 28, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 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, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED HEMOGLOBIN RESULTS ON THE CELL DYN EMERALD ANALYZER FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 13.5 TO 18 G/DL): HEMOGLOBIN RESULT (CELL DYN EMERALD)= 10 G/DL AND 12 G/DL; HEMOGLOBIN RESULT (CELL DYN RUBY)= 6.5 G/DL, 5.5 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096240 ↗
• MalfunctionMar 6, 2024Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE EMANATING FROM THE CELL-DYN 22 EMERALD POWER SUPPLY ON (B)(6) 2024. THE CUSTOMER DISCONNECTED THE POWER SUPPLY. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844585 ↗
• MalfunctionJan 11, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC AND NEUTROPHIL RESULTS GENERATED ON THE CELL-DYN ANALYZER FOR ONE SAMPLE. (CUSTOMER PROVIDED REFERENCE VALUES FOR WBC ARE 4 - 11 10E3/UL) THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6) 05:58 PM: WBC 0.5 10E3/UL NEU 0.3 10E3/UL (B)(6) 2023 SID (B)(6) 06:26 PM REPEAT RESULTS: WBC 5.3 10E3/UL NEU 3.6 10E3/UL THE SAMPLE WAS REPEATED FOR THE THIRD TIME WITH THE FOLLOWING RESULTS: (B)(6) 2023 SID (B)(6) 06:37 PM: WBC 5.3 10E3/UL NEU 3.6 10E3/UL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491125 ↗
• MalfunctionOct 13, 2023High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL-DYN EMERALD ANALYZER FOR MULTIPLE SAMPLES. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 1041, REPEAT RESULT = 236. (B)(6) 2023 SID (B)(6) INITIAL RESULT = 979, REPEAT RESULT = 415 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930120 ↗
• MalfunctionJun 5, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED PLATELET RESULT FOR ONE PATIENT SAMPLE WHEN RUNNING ON THE CELL DYN EMERALD. THE FOLLOWING DATA WAS PROVIDED: 1 EXAMPLE OF PLATELET RESULTS (UNIT OF MEASUREMENT: K/¿L): (B)(6) 2023: 1ST MEASUREMENT 1054 / 2ND MEASUREMENT 234 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059372 ↗
• MalfunctionApr 11, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED PLATELETS GENERATED ON THE CELL-DYN EMERALD FOR A PATIENT WITH AUTOIMMUNE THROMBOCYTOPENIC PURPURA. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023, SAMPLE ID (B)(6); INITIAL RESULT ON THE RUBY (SERIAL NUMBER (B)(6)) = 6.08 10E3/UL, INITIAL RESULT ON EMERALD = 15 10E3/UL, REPEAT = 12 10E3/UL. THE PHYSICIAN QUESTIONED BOTH OF THESE RESULTS AND SENT THEM TO OTHER LABORATORIES FOR TESTING. THE SAME SAMPLE (SID (B)(6)) PROCESSED AT (B)(6) HOSPITAL, RESULT = 75 10E3/UL, AND PROCESSED AT (B)(6) LABORATORY, RESULT = 33 10E3/UL. THE PATIENT WAS DISCHARGED WITH TREATMENT. NO NEGATIVE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718582 ↗
• MalfunctionSep 27, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED FALSELY DEPRESSED HEMOGLOBIN RESULTS WHILE USING THE CELL-DYN EMERALD 22 ANALYZER. THE CUSTOMER PROVIDED AN EXAMPLE THAT THE ANALYZER GENERATED A HEMOGLOBIN RESULT OF 3 MMOL/L INSTEAD OF THE CORRECT VALUE OF 9 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491174 ↗
• MalfunctionAug 24, 2022Patient Data Problem; Patient Data Problem

  THE ACCOUNT STATED THE CELL-DYN EMERALD 22 AL DID NOT READ SOME SAMPLE BARCODES PROPERLY. THE ACCOUNT STATED THAT WHEN SOME BARCODES WERE READ, IT DID NOT READ THEM CORRECTLY AND SHOWED "NO PATIENT ID" IN THEIR AMS. THIS HAPPENED FOR APPROXIMATELY 4 SPECIMENS OUT OF 30 TOTAL. EXAMPLES PROVIDED: CD EMERALD READ: WR478899 BUT SHOULD HAVE BEEN WH478899. CD EMERALD READ: WH4S7837 BUT SHOULD HAVE BEEN WH477837. THE ACCOUNT STATED THE SAME SAMPLE TUBES THAT DID NOT READ PROPERLY WERE PROCESSED ON ANOTHER CELL-DYN EMERALD WHICH READ THE BARCODES PROPERLY. THE SAMPLES WERE READ USING THE AUTO-LOADER. THE ACCOUNT USES BARCODE TYPE CODE 39 WITHOUT CHECK DIGIT. THE ANALYZERS ARE CONNECTED TO LIS/MIDDLEWARE AMS AND RECEIVE ORDERS FROM THE AMS. THE ACCOUNT STATED THE ANALYZERS WERE JUST PUT INTO USE/WENT LIVE THE DAY BEFORE. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283559 ↗
• MalfunctionOct 6, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS FOR SEVERAL PATIENTS ON A CELL-DYN EMERALD ANALYZER. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 130-440 10E3/UL): SAMPLE ID (B)(6) INITIAL RESULT WAS 1214, REPEATED ON A SIEMENS ANALYZER WAS 437 10E3/UL. SAMPLE ID (B)(6) INITIAL RESULT WAS 908, REPEATED ON A SIEMENS ANALYZER WAS 308 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586430 ↗