CELL-DYN 09H46-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 387 adverse event reports that list this exact device (DI 00380740020132), received between Aug 1, 2016 and May 22, 2018 — classified as 387 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (385 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 387 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2018Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH AN UNKNOWN LOT OF CELL-DYN EMERALD CLEANER. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534710 ↗
• MalfunctionFeb 28, 2018Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW ON THE CELL-DYN EMERALD ANALYZER. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF CLEANER THAT THEY WERE USING. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304331 ↗
• MalfunctionJan 10, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY WERE HAVING ISSUES WITH QC ON THE CELL-DYN EMERALD ANALYZER AND HAD TO KEEP REPEATING THEM SEVERAL TIMES. DATA AND REAGENT LOGS WERE REQUESTED BUT WERE NOT PROVIDED. THERE WAS NO REPORT OF INCORRECT PATIENT RESULTS OR ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181277 ↗
• MalfunctionSep 7, 2017Device Sensing Problem

  THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6953. UPON REVIEW OF THE DATA PROVIDED IT WAS DETERMINED THAT BOTH RBC AND PLT CONTROLS WERE OUT OF RANGE LOW. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6849567 ↗
• MalfunctionAug 31, 2017Nonstandard Device; Incorrect Or Inadequate Test Results

  THE CUSTOMER STATED THAT THEY WERE GETTING ALL DASHES FOR QC RESULTS. UPON REVIEW OF QC DATA HISTORY PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT PLT CONTROLS HAD BEEN OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6953. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6835881 ↗
• MalfunctionJul 25, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF AN UNKNOWN LOT OF CELL-DYN EMERALD CLEANER REAGENT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6740721 ↗
• MalfunctionJun 29, 2017Low Test Results; Low Test Results

  UPON REVIEW OF CUSTOMER DATA IT WAS DETERMINED THAT THE CUSTOMER HAD EXPERIENCED RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6991. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6679618 ↗
• MalfunctionJun 27, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6991. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671920 ↗
• MalfunctionFeb 22, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7119. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349919 ↗
• MalfunctionFeb 22, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7110. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349693 ↗
• MalfunctionJan 5, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7027. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6227288 ↗
• MalfunctionDec 19, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7110. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6187612 ↗
• MalfunctionDec 6, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7082. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149757 ↗
• MalfunctionDec 6, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7044. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149721 ↗
• MalfunctionDec 6, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7119. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149556 ↗
• MalfunctionNov 7, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7119. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6084002 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROL VALUES OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7024. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063765 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROL VALUES OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7110. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063745 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROL VALUES OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6991. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063712 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROL VALUES OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7027. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063688 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROL VALUES OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7082. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063644 ↗
• MalfunctionOct 28, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6901. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6063233 ↗
• MalfunctionOct 27, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 6853. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062297 ↗
• MalfunctionOct 27, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC AND PLT CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7024. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062259 ↗
• MalfunctionOct 27, 2016Low Test Results; Low Test Results

  THE CUSTOMER WAS EXPERIENCING RBC CONTROLS OUT OF RANGE LOW WITH THE USE OF CELL-DYN EMERALD CLEANER REAGENT LOT NUMBER 7024. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062181 ↗