CELL-DYN 08H00-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380740016623), received between Nov 8, 2017 and Jul 15, 2022 — classified as 7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 15, 2022Smoking; Smoking

  THE ACCOUNT OBSERVED SMOKE COMING FROM THE BACK OF THE CELL-DYN SAPPHIRE. THE ACCOUNT STATED AFTER A STRANGE SOUND FROM THE LEFT BACKSIDE OF THE ANALYZER, SMOKE WAS SEEN AND A STRANGE ODOR. THE ACCOUNT UNPLUGGED THE POWER CORD. THE ACCOUNT TECHNICAL SERVICE CONFIRMED NOTHING WAS WRONG WITH THE WALL SOCKET OR POWER AT THE ACCOUNT. NO SPECIFIC PATIENT INFORMATION PROVIDED AS THERE WAS NO PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029408 ↗
• MalfunctionJun 18, 2020Leak/Splash; Leak/Splash

  THE CUSTOMER WAS OBSERVING MULTIPLE ISSUES WITH THE CELLDYN SAPPHIRE WITH LIQUID LEAKING OUT OF TUBING BEHIND THE VALVE OF THE ANALYZER. THE CUSTOMER WAS WORKING WITH A FIELD SERVICE ENGINEER (FSE) OVER THE PHONE NEAR THE LEAK AND IT SPRAYED OUT OF THE TUBING. THE CUSTOMER FELT A DROP ON HIS FOREHEAD. THE CUSTOMER WAS NOT WEARING GOGGLES OR A FACE SHIELD. THERE WAS NO INJURY/INTERVENTION TO THE CUSTOMER REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10170382 ↗
• MalfunctionJun 17, 2020High Test Results; High Test Results

  THE ACCOUNT GENERATED FALSE ELEVATED HEMOGLOBIN OF 19 G/DL WITH THE CELL-DYN SAPPHIRE ON PATIENT SAMPLE THAT GENERATED HEMOGLOBIN OF 6 G/DL ON CELL-DYN RUBY. THE ACCOUNT ACCEPTED THE CELL-DYN RUBY RESULTS TO BE CORRECT. NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10160999 ↗
• MalfunctionFeb 10, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER REPORTED THE CELL-DYN SAPPHIRE POWER CORD FROM THE OUTLET IS MELTED AT THE CONNECTION TO THE BACK OF THE UPS. THE CUSTOMER REPORTED THE INSTRUMENT MADE A BEEPING SOUND AND THE TECHNICIAN REPORTED A PLASTIC ODOR, AFTER WHICH THEY UNPLUGGED THE CORD. NO INJURY WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9688923 ↗
• MalfunctionMar 3, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  THE CELL-DYN SAPPHIRE ANALYZER GENERATED A FALSELY ELEVATED PLATELET RESULTS AND LOW %NEUTROPHIL RESULTS. SAMPLE ID (B)(6) GENERATED PLATELET RESULTS OF 21.8, 16.5, 14.9 AND 16.62. ADDITIONALLY, MULTIPLE SAMPLES GENERATED %NEUTROPHIL RESULTS LESS THAN 2.5%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384856 ↗
• MalfunctionJan 2, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING INSTALLATION AFTER DOWNLOADING THE AOS FIRMWARE ON THE CELL-DYN SAPPHIRE ANALYZER, UPON RESTARTING THE INSTRUMENT THERE WAS A BURNING SMELL FROM THE MACHINE AND VISIBLE SMOKE. THE INSTRUMENT WAS SHUT DOWN. ON THE DATA STATION, ERROR 1421 LASER CURRENT TOO HIGH. THE ANALYZER WAS NOT INSTALLED AT THE CUSTOMER SITE. NO INJURIES OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 8209326 ↗
• MalfunctionNov 8, 2017High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED WBC RESULT OF 1630/UL WAS GENERATED IN THE CLOSED MODE ON THE CELL-DYN SAPPHIRE ANALYZER. THE PATIENT WAS KNOWN TO HAVE APLASIA. THE SAMPLE HAD FOLLOWED A VERY HIGH SAMPLE WHICH HAD GENERATED A RESULT OF 258,000/UL. THE CUSTOMER RERAN THE SAMPLE IN THE OPEN MODE AND A WBC RESULT OF 283/UL WAS GENERATED WHICH WAS THE EXPECTED RESULT. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7011358 ↗