Alinity m 09N78-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00884999049208), received between Aug 30, 2022 and Jun 19, 2023 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (42 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 19, 2022Open, Classified

   Reports received of an increase of message code 9186 (internal control failed) when using the kit.

   Z-1679-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738 ON QUALITY CONTROL (QC). ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. INTERNAL CONTROL FAILURES INVALIDATE THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17154000 ↗
• MalfunctionJun 19, 2023Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT#: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES FOR POSITIVE CONTROL (ERROR CODE 9186), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT#: 530738. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152868 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737157 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736649 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736501 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE: 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE: 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736474 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736452 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE: 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731823 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730355 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15730049 ↗
• MalfunctionNov 4, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE: 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE: 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726718 ↗
• MalfunctionNov 3, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723135 ↗
• MalfunctionNov 3, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722290 ↗
• MalfunctionNov 3, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721939 ↗
• MalfunctionNov 3, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721298 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718086 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717389 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717019 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716869 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716667 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738. COMPLAINT TICKET DOCUMENTS: INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085), LOT: 530738 IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT, PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716358 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716302 ↗
• MalfunctionNov 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST: 09N78-085) LOT: 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART: 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716172 ↗
• MalfunctionAug 31, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331291 ↗
• MalfunctionAug 31, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE COMPLAINT INVESTIGATION DETERMINED A PRODUCT DEFICIENCY FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738. COMPLAINT TICKET DOCUMENTS INTERNAL CONTROL FAILURES DUE TO ERROR CODE 9186 (INTERNAL CONTROL FAILED), FOR ALINITY M SARS-COV-2 CONTROL KIT (LIST 09N78-085) LOT 530738, IS HIGHER THAN EXPECTED WHEN COMPARED TO HISTORICAL CONTROL LOT PERFORMANCE. ALINITY M SARS-COV-2 CTRL KIT PART 09N78-085 CONTAINS A POSITIVE CONTROL (PC) AND A NEGATIVE CONTROL (NC). ONE REPLICATE EACH OF THE POSITIVE AND NEGATIVE CONTROL MUST BE VALID FOR THE RUN TO BE VALID. ERROR CODE 9186 (INTERNAL CONTROL FAILED) INVALIDATES THE CONTROL SAMPLE, AND THEREFORE INVALIDATES THE RUN IF THERE IS NO OTHER VALID CONTROL. THE SYSTEM WILL NOT SCHEDULE ANY NEW TESTS WHEN THE QC STATUS IS INVALID. THERE IS NO IMPACT TO PATIENT SAMPLES AS THE SAMPLES ARE PROCESSED INDEPENDENTLY OF THE NEGATIVE CONTROL/POSITIVE CONTROL. THERE IS NO POTENTIAL FOR INCORRECT RESULTS. THIS ISSUE MAY POTENTIALLY CAUSE A DELAY IN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15330999 ↗