CELL-DYN 09H5901Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740020286), received between May 8, 2019 and Sep 19, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED PLATELET GENERATED FROM A CELL-DYN EMERALD AND PROVIDED THE FOLLOWING DATA FOR 2 PATIENTS: CUSTOMER NORMAL PLATELET RANGE 140-442 K/L. PATIENT 1 INITIAL RESULT WAS 1052 AND REPEAT RESULT WAS 268. PATIENT 2 INITIAL RESULT WAS 942 AND REPEAT RESULT WAS 322. CUSTOMER ALSO REPORTED THAT THEY DID NOT REPORT OUT THE INITIAL RESULTS, BUT RATHER THE REPEAT RESULTS. CUSTOMER ALSO STATES INTERMITTENTLY GETTING EMERGENCY STOP AND NOTE THE ANALYZER IS REBOOTED WHICH HELPS WITH RESOLUTION. IT WAS REPORTED THAT FURTHER TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED REPLACEMENT OF ANALYZER PARTS AND A SAMPLE WAS TESTED AND GENERATED PLATELET RESULTS WHICH WERE SIMILAR TO THE RECORDED RESULT OF THE SAMPLE. PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION RECEIVED. THE CUSTOMER PROVIDED FURTHER DETAILS FOR PATIENT 1 AND 2 SAMPLES. PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 1083 AND REPEAT RESULT WAS 268 PATIENT 1 SAMPLE ID WAS (B)(6) AND ON (B)(6) 2024 THE INITIAL PLATELET RESULT WAS 942 AND REPEAT RESULT WAS 322.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262970 ↗
• InjuryOct 17, 2023Unintended Movement; Unintended Movement

  THE CUSTOMER REPORTED THEIR FINGER WAS PUNCTURED WHILE CLEANING THE CELL DYN EMERALD 22 OPEN TUBE ANALYZER. THE CUSTOMER STATED THE INSTRUMENT WAS IN THE ASPIRATION POSITION AND SPLASHED A FEW DROPS OF BLOOD FROM THE LAST SAMPLE BEING PROCESSED. THE CUSTOMER DECIDED TO CLEAN THE ANALYZER BUT MISTAKENLY PRESSED THE ASPIRATION BUTTON ON THE INSTRUMENT CAUSING THE ASPIRATION NEEDLE TO COME OUT AND PUNCTURE THE CUSTOMER¿S FINGER. THE CUSTOMER INDICATES THAT THEY WERE WEARING GLOVES AND THE NEEDLE PUNCTURED THROUGH THE GLOVES AND INJURED THEIR FINGER. THE CUSTOMER FOLLOWED THEIR INTERNAL PROTOCOL AND STARTED TAKING RETROVIRAL MEDICATION (ACRIPTEGA). NO FURTHER MEDICAL TREATMENT OR HARM TO THE USER WAS REPORTED. NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 17952500 ↗
• MalfunctionJun 9, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED PLATELET RESULTS ON CELL-DYN EMERALD ANALYZER FOR ONE ONCOLOGY PATIENTS. THE ONE PATIENT RESULT EXAMPLE PROVIDED ON (B)(6) 2022 WERE: ON (B)(6) 2022 PATIENT B: ON EMERALD=830 K/UL /REPEATED ON ALINITY HQ PROCESSING MODULE=1232 K/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648824 ↗
• MalfunctionDec 14, 2021High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED HEMOGLOBIN RESULT GENERATED ON THE CELL-DYN EMERALD WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 8.8 G/DL, THE PATIENT HAD A NEW SAMPLE DRAWN AT ANOTHER LABORATORY USING SIEMENS SYSMEX = 7.1. THE SAMPLES WERE COLLECTED ON THE SAME DAY AND THE PATIENT DID NOT RECEIVE TREATMENT IN BETWEEN THE BLOOD DRAWS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005658 ↗
• MalfunctionMay 8, 2019High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED WBC RESULT ON THE CELL-DYN EMERALD ANALYZER. THE FOLLOWING DATA WAS PROVIDED: 1ST SAMPLE: CD EMERALD (4AM SAMPLE) WBC 97.7 K/L, BECKMAN LH: 408 K/L, ALINITY H: 407 K/L. 2ND SAMPLE RECOLLECTED SAMPLE AT 7AM SAME DAY: CD EMERALD: 100 K/L, BECKMAN LH: 395 K/L, ALINITY H: 407 K/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8593815 ↗