CELL-DYN 08H67-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380740099916), received between Dec 11, 2016 and May 28, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Low 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED ERRATIC HEMOGLOBIN RESULTS ON THE CELL DYN RUBY ANALYZER FOR ONE PATIENT. THE FOLLOWING RESULTS WERE GENERATED (REFERENCE RANGE 13.5 - 16.5 G/DL): INITIAL HEMOGLOBIN RESULT= 7.5 G/DL; REPEAT RESULT= 8.9 G/DL. UPDATED INFORMATION WAS PROVIDED ON 21MAY2025. PATIENT WAS A 67-YEAR-OLD FEMALE. SAMPLES TESTING WAS PERFORMED ON (B)(6) 2025, SID (B)(6). THE FOLLOWING ADDITIONAL RESULTS WERE PROVIDED: INITIAL WBC RESULT= 11.8 10E3/UL; REPEAT RESULT= 11.5 10E3/UL. INITIAL NEUTROPHIL RESULT= 9.35 10E3/UL; REPEAT RESULT= 9.10 10E3/UL. INITIAL HEMOGLOBIN RESULT= 7.50 G/DL; REPEAT RESULT= 8.59 G/DL. INITIAL PLATELET RESULT=234 10E3/UL; REPEAT RESULT= 232 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095576 ↗
• MalfunctionDec 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER OBSERVED A SAMPLING ASPIRATION ERROR ON THE CELL-DYN RUBY ANALYZER. THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND FOUND CHARRED J17 AND J18 CONNECTOR CABLES AND THE RESPECTIVE CONNECTOR PINS FOR J17 AND J18 ALSO HAD CHARRING. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906257 ↗
• MalfunctionAug 18, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCREPANT WHITE BLOOD CELL (WBC) COUNT RESULTS FOR A LEUKEMIA PATIENT ON A CELL-DYN RUBY ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT, ON (B)(6) 2023, USING NOC MODE WAS 55.7 10E3/UL. THE PATIENT WAS RECOLLECTED ON (B)(6) 2023, AND THE INITIAL RESULT WAS 7.32 10E3/UL, THE SAMPLE WAS REPEATED IN NOC MODE AND THE RESULT WAS 25.1 10E3/UL. THE PATIENT¿S SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE WBC RESULT WAS 16.6 G/I. ALL CBC DATA PROVIDED WAS REVIEWED AND NO OTHER PARAMETERS MEET REPORTING CRITERIA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577783 ↗
• MalfunctionMar 10, 2023Smoking; Smoking

  THE CUSTOMER OBSERVED VISIBLE SMOKE FROM THE CELL-DYN RUBY ANALYZER BUT CANNOT DETERMINE WHERE OR WHICH PARTS IT¿S COMING FROM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO INJURY TO THE USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526628 ↗
• MalfunctionJan 10, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN RESULTS GENERATED ON THE CELL DYN RUBY INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE TESTED MULTIPLE TIMES: 8.9 G/DL, 9.3 G/DL, 9.25 G/DL AND 6.8 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132988 ↗
• MalfunctionJun 1, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN RESULTS ON CELL-DYN RUBY ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=7.4 G/DL /REPEATED=7.8 G/DL /REPEATED ON ANOTHER RUBY (B)(4)=9.4 G/DL /REPEATED=9.8 G/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568543 ↗
• MalfunctionJun 22, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE CELL-DYN RUBY AFTER TRYING TO PERFORM A RESTART WHEN THE INSTRUMENT STOPPED WORKING. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED TROUBLESHOOTING AND OBSERVED MULTIPLE COMPONENTS ON THE PDM BOARD WERE CHARRED AND MELTED. NO INJURIES OR HARM WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10178201 ↗
• MalfunctionDec 22, 2017Smoking; Smoking

  THE CUSTOMER REPORTED OBSERVING VISIBLE SMOKE AND A BURNING SMELL FROM THE CELL DYN RUBY ANALYZER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141713 ↗
• MalfunctionJun 14, 2017Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE COMING FROM THE BACK OF THE CELL-DYN RUBY ANALYZER AND ALSO OBSERVED A BURNING ODOR WHILE THE ANALYZER WAS TURNED ON BUT WAS NOT BEING USED. THEN THE LABORATORY CIRCUIT BREAKER BLEW. THE CIRCUIT BREAKER COULD NOT BE RESTORED UNTIL THE ANALYZER WAS TURNED OFF. NO FIRE OR INJURY WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6642163 ↗
• MalfunctionApr 26, 2017Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT DISCREPANT PLATELET RESULTS WERE GENERATED BY THE CELLDYN RUBY ANALYZER. RESULTS OF 18,600/UL AND 20,100/UL WERE GENERATED. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND RESULTS OF 98,100/UL (PLTO) AND 151,000/UL (PLTI) WERE GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6523360 ↗
• MalfunctionDec 11, 2016High Test Results; High Test Results

  THE CUSTOMER STATED THAT INTERMITTENT FALSELY ELEVATED PLATELET RESULTS WERE GENERATED FOR PATIENT SAMPLES TESTED ON THE CELL-DYN RUBY ANALYZER. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. PATIENT ID (B)(6). FEMALE, DATE OF BIRTH (B)(6) 1989. SAMPLE TESTED ON (B)(6) 2016. INITIAL PLATELET RESULT = 1953 10E9/L, REPEAT PLATELET RESULT = 231 10E9/L. PATIENT ID (B)(6). FEMALE, DATE OF BIRTH (B)(6) 1939. SAMPLE TESTED ON (B)(6) 2016. INITIAL PLATELET RESULT = 1014 10E9/L, REPEAT PLATELET RESULT = 515 10E9/L.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6165463 ↗