CELL-DYN 09H39-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00380740020088), received between Sep 13, 2016 and Sep 2, 2026 — classified as 2 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (63 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 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568805 ↗
• MalfunctionNov 4, 2025Sparking; Sparking

  DURING INSTALLATION OF THE CELL-DYN EMERALD THE ABBOTT FIELD SERVICE ENGINEER (FSE) CONNECTED THE PRINTER, UPS AND BARCODE READER. WHEN THEY THEN POWERED ON THE ANALYZER THEY OBSERVED A LARGE SPARK. THE UPS, CELL-DYN EMERALD AND PRINTER WERE NON-FUNCTIONAL AFTER THIS OCCURRED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464581 ↗
• MalfunctionJan 27, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET (PLT) RESULTS GENERATED ON THE CELL-DYN EMERALD THAT DO NOT MATCH THE PATIENT¿S CLINICAL HISTORY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 140 ¿ 440 K/UL): SAMPLE ID (B)(6) INITIAL RESULT = 76 K/UL, REPEAT RESULT AT ANOTHER LAB ON ANOTHER CELL-DYN EMERALD = 20 K/UL, REPEAT RESULT AT ANOTHER LAB ON BECKMAN COULTER = 9 K/UL. IT WAS NOTED THAT THE CUSTOMER BELIEVES THAT THE RESULTS OF 20 AND 9 ARE CORRECT AS THEY MATCH THE PATIENT¿S CLINICAL HISTORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249039 ↗
• MalfunctionAug 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN (HGB) RESULTS GENERATED ON THE CELL-DYN EMERALD FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2023 SAMPLE ID (B)(6) INITIAL HGB RUN AT LABCORP = 7.9 G/DL (REFERENCE RANGE 11.1-15.9 G/DL), REPEAT ON EMERALD = 9.2 G/DL (REFERENCE RANGE 12.0-15.5 G/DL) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606990 ↗
• MalfunctionJun 19, 2023Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT A PATIENT SAMPLE WAS TESTED THREE TIMES ON THE CELL-DYN EMERALD ANALYZER AND DISCREPANT RESULTS WERE OBSERVED. RESULTS WERE NOT REPORTED TO THE PHYSICIANS. PATIENT 1: 1ST RUN, 2ND RUN, 3RD RUN (EXPECTED VALUES). WBC: 11.1, 1.2, 8.5 (4 - 12 10^3/UL). RBC: 5.52, 1.69, 4.48 (4 - 6.20 10^6/UL). HGB: 13.8, 1.9, 11.0 (11 - 17 G/DL). MCV: 87.9, 88.2, 87.1 (80 - 100 FL). PLT: 496, 365, 116 (150 - 400 10^3/UL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17156307 ↗
• MalfunctionDec 13, 2022Sparking; Sparking

  THE CUSTOMER OBSERVED THE POWER PORT ON THE CELL DYN EMERALD WAS DAMAGED AND WAS LOOSE CAUSING FLASHING AND SPARKS FROM THE POWER PORT WHILE TRYING TO POWER ON THE INSTRUMENT. ONCE THE SPARKS AND FLASHING WERE OBSERVED BY THE CUSTOMER THE INSTRUMENT WAS IMMEDIATELY PUT OUT OF SERVICE. NO FURTHER DAMAGED WAS REPORTED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969149 ↗
• MalfunctionOct 5, 2022Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE FROM AN ELECTRICAL CONNECTION CABLE THAT WAS VISIBLY BURNED ON A CELL-DYN EMERALD INSTRUMENT. THERE WAS NO HARM TO THE USER OR IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544079 ↗
• MalfunctionSep 22, 2022Smoking; Smoking

  THE CUSTOMER OBSERVED SMOKE FROM OUTLET ON THE SIDE OF THE INSTRUMENT WHERE THE REAGENTS ARE LOCATED ON CELL-DYN EMERALD ANALYZER. THE CUSTOMER SMELLED BURNT SMELL. THE SCREEN OF ANALYZER BLACKED OUT. THERE WAS NO VISIBLE FIRE OR SPARK. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO USER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462683 ↗
• MalfunctionAug 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT PLATELET RESULTS GENERATED ON THE CELL DYN EMERALD FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT ((ON SERIAL NUMBER (B)(4)) = 90, REPEATS ((ON SERIAL NUMBER (B)(4)) = 131, 93, 73, 105, AND 111, REPEAT AT ANOTHER LABORATORY = 17. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302617 ↗
• MalfunctionAug 26, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT PLATELET RESULTS GENERATED ON THE CELL DYN EMERALD FOR MULTIPLE SAMPLES. THE FOLLOWING EXAMPLE DATA WAS PROVIDED: INITIAL RESULT ON SERIAL NUMBER (B)(4)= 90, REPEATS ON SERIAL NUMBER (B)(4) = 131, 93, 73, 105, AND 111, REPEAT AT ANOTHER LABORATORY = 17. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302513 ↗
• MalfunctionJun 23, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED HEMOGLOBIN RESULTS GENERATED ON THE CELL DYN EMERALD FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: HGB RESULT EMERALD 7.3 L / SEND OUT RESULT 17.0 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789806 ↗
• MalfunctionMar 27, 2022Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED RESULTS GENERATED WITH THE CELL-DYN EMERALD. THE CUSTOMER DID NOT PROVIDE FULL RESULT DATA, HOWEVER NOTED THAT A SAMPLE INITIALLY RESULTED WITH 7.3 FOR HGB, AND WAS REPEATED AS 18.0. AFTER TROUBLESHOOTING PROCEDURES (DECONTAMINATE PROBE, CLEAN, BACKFLUSH) WERE PERFORMED THE SAMPLE WAS REPEATED WITH A RESULT OF 21.5 (12-16). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925426 ↗
• MalfunctionJan 31, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED HEMOGLOBIN RESULTS GENERATED ON THE CELL-DYN EMERALD INSTRUMENT FOR ONE PATIENT. THE INITIAL HEMOGLOBIN RESULT WAS 9.2 G/DL, REPEATED AT LABCORE 5.3 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13395656 ↗
• MalfunctionNov 22, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL-DYN EMERALD WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): PLATELET: EMERALD =142, REPEAT = 100, ADVIA = 3. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856216 ↗
• MalfunctionAug 23, 2021High Test Results; High Test Results

  THE CUSTOMER QUESTIONED ELEVATED CELL-DYN EMERALD PLATELET (PLT) RESULTS GENERATED FOR A PEDIATRIC PATIENT. SAMPLE: PLATELET RESULTS OF 590 AND 751 K/UL. SAMPLE: PLATELET RESULTS OF 684 AND 1178 K/UL . NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355107 ↗
• MalfunctionJun 21, 2021High Test Results; High Test Results

  THE CUSTOMER OBTAINED A FALSELY ELEVATED PLATELET RESULT WHILE USING THE CELL-DYN EMERALD ANALYZER. ON (B)(6) 2021 THE SAMPLE GENERATED AN INITIAL HIGH RESULT OF 1162 K/UL AND REPEAT OF 303 K/UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033156 ↗
• MalfunctionApr 19, 2021Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED HEMOGLOBIN RESULT GENERATED ON THE CELL DYN EMERALD FOR ONE SAMPLE ON (B)(6) 2021. THE FOLLOWING DATA WAS PROVIDED: HEMOGLOBIN RESULTS = 3.0 G/DL, REPEATS = 10.0 G/DL AND 13.0 G/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685672 ↗
• MalfunctionMar 9, 2021Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER OBSERVED DISCREPANT CBC (COMPLETE BLOOD COUNT) RESULTS FOR MULTIPLE PATIENTS AND CONTROLS OUT OF RANGE ON CELL-DYN EMERALD. THE ONE EXAMPLE PATIENT RESULTS PROVIDED: ON (B)(6) 2021, SID: (B)(6) HEMOGLOBIN=25.0 G/DL / REPEATED AT ANOTHER HOSPITAL=20.0 G/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447083 ↗
• MalfunctionNov 23, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED A HEMOGLOBIN MISMATCH OCCURRING ON THE CELL-DYN EMERALD ANALYZER ON AN (B)(6) YR OLD MALE PATIENT. RESULTS PROVIDED: (B)(6) 2020 SID (B)(6) = 9.2 G/DL (REFERENCE RANGE: 11-18 G/DL), ANOTHER LAB = 6.9 G/DL (REFERENCE RANGE: 14-18 G/DL). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10886667 ↗
• MalfunctionJul 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS NOTIFIED OF THE PRODUCT RECALL FOR THE CELL-DYN EMERALD DILUENT TUBING ON AN IMPACTED CELL-DYN EMERALD ANALYZER. THE DILUENT TUBING WAS REPLACED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10294694 ↗
• MalfunctionJul 13, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS NOTIFIED OF THE PRODUCT RECALL FOR THE CELL-DYN EMERALD DILUENT TUBING ON AN IMPACTED CELL-DYN EMERALD ANALYZER. THE CUSTOMER STATED THE ANALYZER WAS CURRENTLY IN STORAGE BUT ACCESSIBLE FOR TUBING REPLACEMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10263364 ↗
• MalfunctionMay 21, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THE BACKGROUND COUNT WAS TOO HIGH FOR PLT WHILE USING THE CELL-DYN EMERALD ANALYZER. THE FIELD SERVICE ENGINEER WAS UNABLE TO COMPLETE SERVICE DUE TO THE COVID 19 TRAVEL RESTRICTIONS AND IT COULD NOT BE CONFIRMED IF THIS CUSTOMER WAS USING IMPACTED CELL-DYN EMERALD DILUENT TUBING. THERE WAS NO PATIENT INVOLVED AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10080411 ↗
• MalfunctionMay 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS NOTIFIED OF THE PRODUCT RECALL FOR THE CELL-DYN EMERALD DILUENT TUBING ON AN IMPACTED CELL-DYN EMERALD ANALYZER. THE DILUENT TUBING WAS REPLACED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10080319 ↗
• MalfunctionMay 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS NOTIFIED OF THE PRODUCT RECALL FOR THE CELL-DYN EMERALD DILUENT TUBING ON AN IMPACTED CELL-DYN EMERALD ANALYZER. THE DILUENT TUBING WAS REPLACED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10080136 ↗
• MalfunctionMay 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER WAS NOTIFIED OF THE PRODUCT RECALL FOR THE CELL-DYN EMERALD DILUENT TUBING ON AN IMPACTED CELL-DYN EMERALD ANALYZER. THE DILUENT TUBING WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10080079 ↗