Alinity m 09N78-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 357 adverse event reports that list this exact device (DI 00884999049222), received between Feb 10, 2021 and Dec 11, 2024 — classified as 357 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (344 reports).

3 FDA recall records name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Sep 2, 2021Class ITerminated

   There is a potential for false positive results.

   Z-0004-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Sep 2, 2021Class ITerminated

   There is a potential for false positive results.

   Z-0006-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. Sep 2, 2021Class ITerminated

   There is a potential for false positive results.

   Z-0007-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 357 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 2 FALSE POSITIVES ON THE SARS-COV-2 ASSAY. ON (B)(6) 2024, THE CUSTOMER HAD A REACTIVE NEGATIVE CONTROL ON THE SARS-COV-2 ASSAY. THE CUSTOMER THEN REPORTED THAT 2 SAMPLES WERE POSITIVE ON ALINITY BUT WERE RERUN ON CEPHEID AND RESULTED NEGATIVE. SAMPLE ID (SID) (B)(6) WAS TESTED ON (B)(6) 2024 AND WAS POSITIVE FOR SARS-COV-2. IT WAS NOT REPORTED DUE TO SUSPECTED CONTAMINATION. SID (B)(6) WAS TESTED ON (B)(6) 2024 WAS POSITIVE FOR SARS-COV-2. THE SAMPLE WAS TESTED AGAIN THE SAME DAY AND WAS NEGATIVE. THE RESULT WAS CONSIDERED INCONCLUSIVE AND WAS NOT REPORTED FOR THIS PATIENT. THE CUSTOMER TESTED SOME WATER SAMPLES AND TWO WERE POSITIVE FOR SARS-COV-2. THE CUSTOMER PROCEEDED TO DECONTAMINATE THE INSTRUMENT. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905962 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6). RUN DATE (B)(6) 2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 38.53), REPEATED ON (B)(6)2023 UNDER SID (B)(6) RESULT NEGATIVE (CN -1). RUN DATE (B)(6)2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 39.84), REPEATED ON (B)(6)2023 UNDER SID (B)(6) RESULT NEGATIVE (CN -1). RUN DATE (B)(6) 2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 40.18), REPEATED ON (B)(6)2023 UNDER SID (B)(6) RESULT NEGATIVE (CN -1). RUN DATE (B)(6)2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 38.08), REPEATED (B)(6)2023 WITH RESULT POSITIVE (CN 39.66) AND (B)(6)2023 UNDER SID (B)(6) RESULT NEGATIVE (CN -1). RUN DATE (B)(6)2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 39.03), REPEATED ON (B)(6)2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1). RUN DATE (B)(6)2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 38.65), REPEATED ON (B)(6)2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1). RUN DATE (B)(6) SID (B)(6) INITIAL RESULT POSITIVE (C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016958 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6): RUN DATE: (B)(6) 2023; SID: (B)(6); INITIAL RESULT POSITIVE (CN 38.26), REPEATED ON: (B)(6) 2023 UNDER SID: (B)(6); RPT RESULT NEGATIVE (CN -1). RUN DATE: (B)(6) 2023; SID: (B)(6); INITIAL RESULT POSITIVE (CN 38.67), REPEATED ON: (B)(6) 2023 UNDER SID: (B)(6); RPT RESULT NEGATIVE (CN -1). RUN DATE: (B)(6) 2023; SID: (B)(6); INITIAL RESULT POSITIVE (CN 39.58), REPEATED ON: (B)(6) 2023 UNDER SID: (B)(6); RPT RESULT NEGATIVE (CN -1). RUN DATE: (B)(6) 2023; SID: (B)(6); INITIAL RESULT POSITIVE (CN 41.27), REPEATED ON: (B)(6) 2023 UNDER SID: (B)(6); RPT RESULT NEGATIVE (CN -1). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016957 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6) 2023: RUN DATE (B)(6) 2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 40.08), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1) THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016956 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6): RUN DATE (B)(6) 2023, SID (B)(6),INITIAL RESULT POSITIVE (CN 39.05), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1). RUN DATE (B)(6) 2023, SID (B)(6), INITIAL RESULT POSITIVE (CN 41.19), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RP RESULT NEGATIVE (CN -1). RUN DATE (B)(6) 2023, SID (B)(6), INITIAL RESULT POSITIVE (CN 38.25), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016955 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6): RUN DATE (B)(6) 2023; SID (B)(6); INITIAL RESULT POSITIVE (CN 40.51), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1), RUN DATE (B)(6) 2023; SID (B)(6); INITIAL RESULT POSITIVE (CN 38.41), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RPT RESULT NEGATIVE (CN -1). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016954 ↗
• MalfunctionOct 26, 2023False Positive Result; False Positive Result

  THE CUSTOMER IDENTIFIED FALSELY POSITIVE ALINITY M SARS-COV-2 RESULTS FOR FORTY PATIENTS. THE CUSTOMER NOTED THAT AS A ROUTINE MATTER, ANY RESULT WITH A CYCLE NUMBER (CN) >35 IS USUALLY REPEATED. THE CUSTOMER PROVIDED RESULTS FOR 29 SAMPLES. THE FOLLOWING SID(S) OCCURRED ON THE DATE OF EVENT (B)(6) : RUN DATE (B)(6) 2023 SID (B)(6) INITIAL RESULT POSITIVE (CN 40.09), REPEATED ON (B)(6) 2023 UNDER SID (B)(6) RESULT NEGATIVE (CN -1) THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016953 ↗
• MalfunctionSep 5, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED 1 FALSE NEGATIVE (NOT DETECTED) RESULT ON THE ALINITY M SARS-COV-2 ASSAY. SAMPLE ID (SID) (B)(6). WAS TESTED ON (B)(6) 2023 ON THE ALINITY M SARS-COV-2 ASSAY AND THE RESULT WAS "NOT DETECTED." THE CUSTOMER REPORTED THAT THE PATIENT WAS A STAFF MEMBER OF THE HOSPITAL WHO HAD TESTED POSITIVE WITH TWO AT-HOME SARS-COV-2 TESTS (QUICKVUE AT-HOME OTC COVID-19 TEST AND QUIDEL). THE NURSE MANAGING THE CASE ALSO NOTED THAT THE PATIENT WAS SYMPTOMATIC. THE STAFF MEMBER (PATIENT) HAD TESTED NEGATIVE FOR SARS-COV-2 ON BOTH THE ALINITY M SYSTEM AS WELL AS ON THE GENEXPERT. THE RESULTS WERE REPORTED TO THE NURSE MONITORING THE STAFF MEMBER AND THE NURSE REPORTED THAT THE STAFF MEMBER WAS SYMPTOMATIC AND HAD TESTED POSITIVE ON AN AT-HOME TEST. THE TECHNICAL APPLICATION SPECIALIST (TAS) DOWNLOADED THE ALINITY M LOGS FOR THE SAMPLE IN QUESTION. THE GRAPHS FOR THE SAMPLE APPEARED NORMAL. THE INTERNAL CONTROL FOR THE SAMPLE WAS NORMAL AND NO ERROR CODES WERE PRESENT FOR THE SAMPLE. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684872 ↗
• MalfunctionApr 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 1 FALSE POSITIVE RESULT ON THE ALINITY M SARS-COV-2 ASSAY. SID (B)(6) TESTED ON (B)(6) 2023 GAVE POSITIVE RESULTS WHEN TESTED AND WHEN RETESTED USING A RECOLLECTED SAMPLE, GAVE NEGATIVE RESULT. THE FALSE POSITIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND PATIENT SAMPLE HAD TO BE RECOLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725792 ↗
• MalfunctionApr 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 1 FALSE POSITIVE RESULT ON THE ALINITY M SARS COV 2 ASSAY. SID SAMPLE ID (B)(6) TESTED ON (B)(6) 2023 GAVE POSITIVE RESULTS WHEN TESTED AND WHEN RETESTED USING A RECOLLECTED SAMPLE, GAVE NEGATIVE RESULT. THE FALSE POSITIVE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND PATIENT SAMPLE HAD TO BE RECOLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725791 ↗
• MalfunctionApr 12, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 3 FALSE POSITIVE RESULTS ON THE ALINITY M SARS-COV-2 ASSAY. SID (B)(6) TESTED ON (B)(6) 2023, GAVE POSITIVE RESULTS WHEN TESTED AND WHEN RETESTED USING A RECOLLECTED SAMPLE, GAVE NEGATIVE RESULT. THE FALSE POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND PATIENT SAMPLES HAD TO BE RECOLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725790 ↗
• MalfunctionFeb 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN ADDITONAL FALSE POSITIVE RESULT THAT OCCURRED ON (B)(6) 2022 FOR SAMPLE ID (SID) (B)(6) ON ALINITY M SARS-COV-2 AMP KIT (LIST 09N78-095) LOT 381032. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THIS EVENT IS BEING REPORTED WITH THE FOLLOWING MDR: 3005248192-2022-01020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16313065 ↗
• MalfunctionJan 31, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTED AN ADDITIONAL FALSE NEGATIVE RESULT THAT OCCURRED ON (B)(6) 2022 FOR SAMPLE ID (SID) (B)(6) ON ALINITY M RESP-4-PLEX ASSAY LOT NUMBER 382437. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. THIS EVENT IS BEING REPORTED WITH THE FOLLOWING MDR: 3005248192-2022-01248.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274580 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN 371. SIDS (SAMPLE IDS) (B)(6), (B)(6), (B)(6) AND (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249184 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249175 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) WERE RUN ON 08/31/2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249174 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249173 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249157 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) AND (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249156 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249155 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN 371. SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249152 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249151 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249150 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SIDS (SAMPLE IDS) (B)(6) WERE RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249149 ↗
• MalfunctionJan 26, 2023False Positive Result; False Positive Result

  THIS REPORT WAS PREVIOUSLY REPORTED IN 3005248192-2022-01050, 3005248192-2022-01051 AND 3005248192-2022-01052 AND IS BEING CORRECTED TO ENSURE ONE MDR IS SENT PER RUN FOR THIS EUA PRODUCT. THE CUSTOMER REPORTED 60 DISCREPANT RESULTS FOR THE ALINITY M SARS-COV-2 ASSAY ON THE ALINITY M INSTRUMENTS SN (B)(4). SID (SAMPLE ID) (B)(6) WAS RUN ON (B)(6) 2022 AND GAVE A POSITIVE RESULT FOR SARS-COV-2. WHEN RETESTED, A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER'S SOP REQUIRES THEM TO RETEST UNDER THE THRESHOLD. THE CUSTOMER USUALLY RETESTS IMMEDIATELY AFTER RECEIVING RESULT; HOWEVER, SOME RESULTS REPORTED AS PART OF THIS EVENT WERE HELD IN THE REFRIGERATOR FOR 2 HOURS AND FROM WERE HELD IN THE FREEZER FOR 6-8 HOURS BEFORE RE-TESTING. CUSTOMER WAS UNABLE TO SPECIFY WHICH SID'S WERE RE-TESTED IMMEDIATELY. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ACCORDING TO THE CUSTOMER, APPROXIMATELY 25% OF THE SAMPLE SIZE (101 SAMPLES) WERE PRE-PROCEDURE SCREENING. PROCEDURES WOULD HAVE BEEN RE-SCHEDULED IF REPORTED "DETECTED." THE OTHER 75% OF THE SAMPLE SIZE WAS COMPRISED OF EMPLOYEE SCREENING INCLUDING NURSING HOME STAFF. NURSING HOME STAFF WITH RESULTS "DETECTED" CAUSE A MAJOR SCREENING EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16249148 ↗