AQUIOS CLRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 15099590225889), received between Aug 29, 2017 and Jul 8, 2025 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (29 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED A DELAY OF RESULTS FOR CD34+ ON ONE PATIENT DUE TO DESTRUCTION OF THE SPECIMEN WHEN THEIR AQUIOS CL FLOW CYTOMETER CRASHED BECAUSE OF A MOTION COMMUNICATION FAILURE. THE SPECIMEN HAD TO BE REDRAWN CAUSING A DELAY OF RESULTS. NO ERRONEOUS RESULTS WERE GENERATED. THERE WERE NO REPORTS OF SERIOUS HARM TO PATIENT OR OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440841 ↗
• InjurySep 10, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE AQUIOS CL FLOW CYTOMETER WASTE CONNECTOR BROKE, RESULTING IN A LEAKAGE OF WASTE FLUID. THE OPERATOR WAS EXPOSED TO THE LEAKED FLUID WHILE INVESTIGATING THE ORIGIN OF THE LEAK. THE OPERATOR WAS WEARING ONLY GLOVES AS PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. WHILE LEANING INTO THE INSTRUMENT, THE OPERATOR¿S MOUTH AND EYES WERE EXPOSED TO THE WASTE FLUID. THE OPERATOR SOUGHT MEDICAL ATTENTION AND IS RECEIVING ANTIRETROVIRAL TREATMENT FOR 28 DAYS AS A RESULT OF THE EVENT. OPERATORS IN THIS LABORATORY WILL NOW USE A MASK WITH A VISOR IN ADDITION TO GLOVES WHILE TROUBLESHOOTING THE INSTRUMENTS. THERE WAS NO IMPACT TO PATIENT OR PATIENT SAMPLES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185721 ↗
• MalfunctionOct 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT WHEN RUNNING SAMPLES ON THE AQUIOS CL FLOW CYTOMETRY SYSTEM THEY OBTAINED VERY LOW VALUES AND WHEN THEY RERUN THE SAME SAMPLE, THEY OBTAINED VERY HIGH VALUES. ERRONEOUS RESULTS WERE GENERATED BUT NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543198 ↗
• MalfunctionNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCREPANT CD4 COUNTS ON THE AQUIOS CL. RESULTS WERE REVIEWED AND NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828130 ↗
• MalfunctionFeb 10, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THE AQUIOS CL IS GENERATING RESULTS WITH "PLG COUNT FAILED" NOTIFICATIONS. REVIEW OF THE DATA PROVIDED INDICATE THAT ERRONEOUSLY HIGH CD4 RESULTS WERE GENERATED FOR SEVERAL SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309407 ↗
• MalfunctionJul 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED CARRYOVER FAILURE ON THEIR AQUIOS CL FLOW CYTOMETRY SYSTEM WHEN RUNNING THE CD4-PLG SYSTEM. IT IS UNKNOWN IF ERRONEOUS PATIENT RESULTS WERE GENERATED; CONFIRMATION WAS REQUESTED FROM THE CUSTOMER BUT NOT PROVIDED. THERE IS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306022 ↗
• MalfunctionJul 9, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THERE WAS A LOSS OF GROUND RESULTING IN AN ELECTRICAL SHOCK TO A TECHNICAL SUPPORT SPECIALIST WHO WAS ASSISTING THE FIELD SERVICE ENGINEER DURING TROUBLESHOOTING ON AN AQUIOS CL. THE TECHNICAL SUPPORT SPECIALIST DID NOT REQUIRE MEDICAL ATTENTION AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Electric Shock

  MAUDE report 10256065 ↗
• MalfunctionJul 7, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training

  THE CUSTOMER REPORTED POTENTIAL SAMPLE OR GATING ISSUE NOTIFICATIONS AND NOTIFICATION OF (B)(6) CD8 FOR PATIENT SAMPLES ON THE AQUIO CL FLOW CYTOMETER. NEW INFORMATION RECEIVED 8 JUNE 2020 INDICATES THAT AN (B)(6) CD4 COUNT/UL (CD3+/CD4+, HELPER T CELLS) WAS RELEASED TO THE PHYSICIAN. AN (B)(6) CD4 COUNT/UL PATIENT RESULT (PER THE CUSTOMER) WAS GENERATED, FLAGGED BY THE INSTRUMENT WITH RUN NOTIFICATIONS BUT WAS REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF CHANGE OR EFFECT TO PATIENT TREATMENT WITH THE INITIAL INFORMATION RECEIVED. THE PHYSICIAN QUESTIONED THE RESULT AND ORDERED REPEAT TESTING. THE PATIENT IS A KNOWN (B)(6) PATIENT AND IT IS UNCLEAR IF THERE WAS A CHANGE OR A DELAY TO PATIENT TREATMENT. THE INFORMATION REGARDING TREATMENT HAS BEEN UNCLEAR AND SPECIFICS HAVE BEEN REQUESTED BUT NOT PROVIDED.

  Patient problems: Test Result

  MAUDE report 10239340 ↗
• MalfunctionSep 27, 2018Output Problem; Output Problem

  (B)(4) DATABASE REVIEW IDENTIFIED SUSPECT DUPLICATE SAMPLE RUNS. FIELD ACTION (B)(4) PROVIDES INFORMATION TO CUSTOMERS CONCERNING A SOFTWARE ISSUE WHICH MAY RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THIS CAN OCCUR WHEN USING THE AQUIOS CL SYSTEMS CONNECTED TO A LABORATORY INFORMATION SYSTEM (LIS). ALL AQUIOS SYSTEMS SUSCEPTIBLE TO THE LIS ISSUE OUTLINED IN FIELD ACTION (B)(4) REQUIRES DATA RETRIEVAL PER SERVICE (B)(4) FOR ANALYSIS TO DETERMINE IF ANY OF THE AVAILABLE PATIENT RESULT DATA HAS BEEN IMPACTED. ANALYSIS OF THE FILES FROM AQUIOS SN: (B)(4) FOUND 2 INCIDENTS THAT MATCHED THE PATTERN OF THE KNOWN SOFTWARE ISSUE. SAMPLE ID- (B)(6), (B)(6) 2016. SAMPLE ID- (B)(6), (B)(6) 2016.

  Patient problems: Test Result

  MAUDE report 7914324 ↗
• MalfunctionMay 23, 2018Device Operational Issue; Device Operational Issue

  ON (B)(6) 2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WERE SEVEN SAMPLE IDS ON (B)(6) 2017, AND SAMPLE ID ON (B)(6) 2017 THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: (B)(4).

  Patient problems: Test Result

  MAUDE report 7538597 ↗
• MalfunctionMay 23, 2018Device Operational Issue; Device Operational Issue

  ON (B)(6) 2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WERE SEVEN SAMPLE IDS ON (B)(6) 2017, AND SAMPLE ID ON (B)(6) 2017 THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: (B)(6).

  Patient problems: Test Result

  MAUDE report 7538493 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  ON 25-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WERE NINE SAMPLE IDS ON 26-JUL-2017, THERE WERE FIVE SAMPLE IDS ON 07-DEC-2017, AND 4 SAMPLE IDS ON 22-FEB-2018 THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID SAMPLE ID: (B)(6); (B)(6) 2017 .

  Patient problems: Test Result

  MAUDE report 7531896 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  ON 25-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WERE NINE SAMPLE IDS ON (B)(6) 2017, THERE WERE FIVE SAMPLE IDS ON (B)(6) 2017, AND 4 SAMPLE IDS ON (B)(6) 2018 THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018.

  Patient problems: Test Result

  MAUDE report 7531848 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  ON 25-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WERE NINE SAMPLE IDS ON (B)(6) 2017, THERE WERE FIVE SAMPLE IDS ON (B)(6) 2017, AND 4 SAMPLE IDS ON (B)(6) 2018 THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018. SAMPLE (B)(6), (B)(6) 2018.

  Patient problems: Test Result

  MAUDE report 7531813 ↗
• MalfunctionMay 18, 2018Device Operational Issue; Device Operational Issue

  ON 25-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER AW19012, THERE WAS ONE INCIDENT ON (B)(6) 2016 THAT MATCHES THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2016. SAMPLE (B)(6), (B)(6) 2016.

  Patient problems: Test Result

  MAUDE report 7527572 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON (B)(6) 2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WAS TWO INCIDENTS ON (B)(6) 2017 (1061932-2018-00020), TWO INCIDENTS ON (B)(6) 2017 (1061932-2018-00021), FOUR INCIDENTS ON (B)(6) 2017 (1061932-2018-00022), AND THREE INCIDENTS ON (B)(6) 2017 (1061932-2018-00023) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: O SAMPLE ID (B)(6) - (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519368 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS TWO INCIDENTS ON (B)(6)2017 (THIS REPORT), TWO INCIDENTS ON (B)(6) 2017 (1061932-2018-00021), FOUR INCIDENTS ON (B)(6) 2017 (1061932-2018-00022), AND THREE INCIDENTS ON (B)(6) 2017 (1061932-2018-00023) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519359 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS TWO INCIDENTS ON (B)(6)2017 (1061932-2018-00020), TWO INCIDENTS ON (B)(6) 2017 (1061932-2018-00021), FOUR INCIDENTS ON (B)(6) 2017 (THIS REPORT), AND THREE INCIDENTS ON (B)(6) 2017 (1061932-2018-00023) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519345 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS TWO INCIDENTS ON (B)(6)2017 (1061932-2018-00020), TWO INCIDENTS ON (B)(6) 2017 (1061932-2018-00021), FOUR INCIDENTS ON (B)(6) 2017 (1061932-2018-00022), AND THREE INCIDENTS ON (B)(6) 2017 (THIS REPORT) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519331 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS ONE INCIDENT ON (B)(6)2017 (1061932-2018-00024), TEN INCIDENTS ON (B)(6) 2017 (THIS REPORT), AND THREE INCIDENTS ON (B)(6) 2018 (1061932-2018-00026) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017. (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519311 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS ONE INCIDENT ON (B)(6)2017 (THIS REPORT), TEN INCIDENTS ON (B)(6) 2017 (1061932-2018-00025), AND THREE INCIDENTS ON (B)(6) 2018 (1061932-2018-00026) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017. SAMPLE (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519290 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  ON 13-APRIL-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WAS ONE INCIDENT ON (B)(6) 2017 (1061932-2018-00024), TEN INCIDENTS ON (B)(6) 2017 (1061932-2018-00025), AND THREE INCIDENTS ON (B)(6) 2018 (1061932-2018-00026) THAT MATCH THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6). (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017, SAMPLE ID (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7519273 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  ON 23-MARCH-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL (B)(4), THERE WAS ONE INCIDENT ON (B)(6) 2017 (1061932-2018-00016), ONE ON (B)(6) 2017 (1061932-2018-00017) AND ONE INCIDENT IN (B)(6) 2017 (THIS REPORT) THAT MATCHES THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: (B)(6), DATE: (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017; (B)(6), (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7445945 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  ON (B)(6) 2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(6), THERE WAS ONE INCIDENT ON (B)(6) 2017 ((B)(4)), ONE ON (B)(6) 2017 ((B)(4)) AND ONE INCIDENT IN (B)(6) 2017 ((B)(4)) THAT MATCHES THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: (B)(6).

  Patient problems: Test Result

  MAUDE report 7445943 ↗
• MalfunctionApr 20, 2018Device Operational Issue; Device Operational Issue

  ON 23-MARCH-2018, BECKMAN COULTER (BEC) REVIEWED THE INFORMATION EXTRACTED FROM THE DATABASE OF THE CUSTOMER'S AQUIOS CL FLOW CYTOMETRY INSTRUMENT TO DETERMINE IF ANY RESULTS WERE IMPACTED BY THE AQUIOS CL LABORATORY INFORMATION SYSTEM (LIS) ISSUE, WHICH COULD RESULT IN DUPLICATE SAMPLE REQUESTS LEADING TO SAMPLE MIS-IDENTIFICATION. THE ANALYSIS REPORT, INDICATES THAT FOR INSTRUMENT SERIAL NUMBER (B)(4), THERE WAS ONE INCIDENT ON (B)(6) 2017 (1061932-2018-00016), ONE ON (B)(6) 2017 (1061932-2018-00017) AND ONE INCIDENT IN (B)(6) 2017 (1061932-2018-00018) THAT MATCHES THE PATTERN OF THE KNOWN SOFTWARE ISSUE. THE SAMPLE IDS THAT MAY HAVE BEEN MIS-IDENTIFIED ARE AS FOLLOWS: SAMPLE ID: (B)(6) DATE: (B)(6) 2017.

  Patient problems: Test Result

  MAUDE report 7445942 ↗