Alinity m 09N79-096Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00884999049390), received between Nov 1, 2021 and Apr 11, 2026 — classified as 179 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (160 reports).

2 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 16, 2026.

Recalls naming this device

1. Sep 2, 2021Terminated

   There is a potential for false positive results.

   Z-0008-2022 · Root cause: Device Design · Recall details · FDA record ↗

2. Sep 2, 2021Terminated

   There is a potential for false positive results.

   Z-0005-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (02) FALSE POSITIVE RESULTS FOR THE RSV TARGET ON THE ALINITY M RESP-4-PLEX AMP KIT. PATIENT 1: SAMPLE ID (SID): (B)(6) WAS PROCESSED ON (B)(6) 2026 AND RESULTED AS RSV POSITIVE WITH A CYCLE THRESHOLD (CT) VALUE OF 39.11. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT FOR RSV. PATIENT 2 (15-MONTH-OLD PATIENT): SID: (B)(6) WAS PROCESSED ON (B)(6) 2026 AND RESULTED AS RSV POSITIVE WITH A CT VALUE OF 39.10. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT. THE SPECIMEN TYPE WAS A NASOPHARYNGEAL (NP) SWAB COLLECTED IN BD UNIVERSAL VIRAL TRANSPORT (UVT). REPEAT TESTING WAS PERFORMED USING THE ORIGINAL SAMPLE TUBE. AT THE CUSTOMER SITE FOR MULTIPLEX ASSAYS IF TWO OR MORE TARGETS RETURN A POSITIVE RESULT, THE SAMPLE IS RETESTED ON ANOTHER PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846973 ↗
• MalfunctionApr 10, 2026False Positive Result

  THE CUSTOMER REPORTED TWO (02) FALSE POSITIVE RESULTS FOR THE RSV TARGET ON THE ALINITY M RESP-4-PLEX AMP KIT. PATIENT 1: SAMPLE ID (SID): (B)(6) WAS PROCESSED ON 16-MAR-2026 AND RESULTED AS RSV POSITIVE WITH A CYCLE THRESHOLD (CT) VALUE OF 39.11. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT FOR RSV. PATIENT 2 (15-MONTH OLD PATIENT): SID: (B)(6) WAS PROCESSED ON 10-MAR-2026 AND RESULTED AS RSV POSITIVE WITH A CT VALUE OF 39.10. REPEAT TESTING ON THE CEPHEID PLATFORM PRODUCED A NOT DETECTED RESULT. THE SPECIMEN TYPE WAS A NASOPHARYNGEAL (NP) SWAB COLLECTED IN BD UNIVERSAL VIRAL TRANSPORT (UVT). REPEAT TESTING WAS PERFORMED USING THE ORIGINAL SAMPLE TUBE. AT THE CUSTOMER SITE FOR MULTIPLEX ASSAYS IF TWO OR MORE TARGETS RETURN A POSITIVE RESULT, THE SAMPLE IS RETESTED ON ANOTHER PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840566 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS ON THE RSV TARGET WHILE USING THE ALINITY M RESP-4-PLEX AMP KIT. THE FOLLOWING 5 SAMPLE IDS (SIDS) SHOWED A WEAK POSITIVE RSV RESULT AND GENERATED A NEGATIVE RESULT ON REPEAT: (B)(6) DATE OF TESTING: 7-25 (B)(6) DATE OF TESTING: 7-29 (B)(6) DATE OF TESTING: 7-30 (B)(6) DATE OF TESTING: 8-5 (B)(6) DATE OF TESTING: 8-6. CUSTOMER PERFORMED ENVIRONMENTAL TESTING. CUSTOMER USED WET SWABS TO COLLECT SAMPLES FROM INSTRUMENT TOUCH POINTS, CENTRIFUGE, BENCHES, PIPETTES, HOODS, VORTEXES, AND SAMPLE PROCESSING AREA SINK. ALL SAMPLES WERE NEGATIVE. TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED RESULT HISTORY FOR THE PRIOR 30 DAYS. NO REACTIVE NEGATIVE QUALITY CONTROL (QC) SAMPLES ARE PRESENT. ONLY 1 INTERNAL CONTROL ERROR WAS PRESENT. 5 CELLULAR CONTROL ERRORS WERE PRESENT. 5 PIPETTING ERRORS WERE PRESENT. OVERALL COMPLETION RATE FOR THE PRIOR 30 DAYS IS 97.2%. BETWEEN (B)(6) 2025 2 POSITIVE RSV RESULTS WERE PRESENT OUT OF 201 SAMPLES INDICATING A 1.0% POSITIVITY RATE, WITH ALL CYCLE NUMBERS (CN) <25. BETWEEN (B)(6) 2025 5 POSITIVE RSV RESULTS WERE PRESENT OUT OF 240 SAMPLES INDICATING A 2.1% POSITIVITY RATE, WITH ALL CN >39. FALSE POSITIVE RESU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926211 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS ON THE RSV TARGET WHILE USING THE ALINITY M RESP-4-PLEX AMP KIT. THE FOLLOWING 5 SAMPLE IDS (SIDS) SHOWED A WEAK POSITIVE RSV RESULT AND GENERATED A NEGATIVE RESULT ON REPEAT: (B)(6) DATE OF TESTING: (B)(6). (B)(6) DATE OF TESTING: (B)(6). (B)(6) DATE OF TESTING: (B)(6). (B)(6) DATE OF TESTING: (B)(6). (B)(6) DATE OF TESTING: (B)(6). CUSTOMER PERFORMED ENVIRONMENTAL TESTING. CUSTOMER USED WET SWABS TO COLLECT SAMPLES FROM INSTRUMENT TOUCH POINTS, CENTRIFUGE, BENCHES, PIPETTES, HOODS, VORTEXES, AND SAMPLE PROCESSING AREA SINK. ALL SAMPLES WERE NEGATIVE. TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED RESULT HISTORY FOR THE PRIOR 30 DAYS. NO REACTIVE NEGATIVE QUALITY CONTROL (QC) SAMPLES ARE PRESENT. ONLY 1 INTERNAL CONTROL ERROR WAS PRESENT. 5 CELLULAR CONTROL ERRORS WERE PRESENT. 5 PIPETTING ERRORS WERE PRESENT. OVERALL COMPLETION RATE FOR THE PRIOR 30 DAYS IS 97.2%. BETWEEN (B)(6) 2025 2 POSITIVE RSV RESULTS WERE PRESENT OUT OF 201 SAMPLES INDICATING A 1.0% POSITIVITY RATE, WITH ALL CYCLE NUMBERS (CN) <25. BETWEEN (B)(6) 2025 5 POSITIVE RSV RESULTS WERE PRESENT OUT OF 240 SAMPLES INDICATING A 2.1% POSITIVITY RATE, WITH ALL CN >39. FAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926210 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS ON THE RSV TARGET WHILE USING THE ALINITY M RESP-4-PLEX AMP KIT. THE FOLLOWING 5 SAMPLE IDS (SIDS) SHOWED A WEAK POSITIVE RSV RESULT AND GENERATED A NEGATIVE RESULT ON REPEAT: (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6). CUSTOMER PERFORMED ENVIRONMENTAL TESTING. CUSTOMER USED WET SWABS TO COLLECT SAMPLES FROM INSTRUMENT TOUCH POINTS, CENTRIFUGE, BENCHES, PIPETTES, HOODS, VORTEXES, AND SAMPLE PROCESSING AREA SINK. ALL SAMPLES WERE NEGATIVE. TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED RESULT HISTORY FOR THE PRIOR 30 DAYS. NO REACTIVE NEGATIVE QUALITY CONTROL (QC) SAMPLES ARE PRESENT. ONLY 1 INTERNAL CONTROL ERROR WAS PRESENT. 5 CELLULAR CONTROL ERRORS WERE PRESENT. 5 PIPETTING ERRORS WERE PRESENT. OVERALL COMPLETION RATE FOR THE PRIOR 30 DAYS IS 97.2%. BETWEEN (B)(6) 2025, 2 POSITIVE RSV RESULTS WERE PRESENT OUT OF 201 SAMPLES INDICATING A 1.0% POSITIVITY RATE, WITH ALL CYCLE NUMBERS (CN) <25. BETWEEN (B)(6) 2025, 5 POSITIVE RSV RESULTS WERE PRESENT OUT OF 240 SAMPLES INDICATING A 2.1% POSITIVITY RATE, WITH ALL CN >39. F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926209 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS ON THE RSV TARGET WHILE USING THE ALINITY M RESP-4-PLEX AMP KIT. THE FOLLOWING 5 SAMPLE IDS (SIDS) SHOWED A WEAK POSITIVE RSV RESULT AND GENERATED A NEGATIVE RESULT ON REPEAT: (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6), (B)(6) DATE OF TESTING: (B)(6). CUSTOMER PERFORMED ENVIRONMENTAL TESTING. CUSTOMER USED WET SWABS TO COLLECT SAMPLES FROM INSTRUMENT TOUCH POINTS, CENTRIFUGE, BENCHES, PIPETTES, HOODS, VORTEXES, AND SAMPLE PROCESSING AREA SINK. ALL SAMPLES WERE NEGATIVE. TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED RESULT HISTORY FOR THE PRIOR 30 DAYS. NO REACTIVE NEGATIVE QUALITY CONTROL (QC) SAMPLES ARE PRESENT. ONLY 1 INTERNAL CONTROL ERROR WAS PRESENT. 5 CELLULAR CONTROL ERRORS WERE PRESENT. 5 PIPETTING ERRORS WERE PRESENT. OVERALL COMPLETION RATE FOR THE PRIOR 30 DAYS IS 97.2%. BETWEEN (B)(6) 2025, 2 POSITIVE RSV RESULTS WERE PRESENT OUT OF 201 SAMPLES INDICATING A 1.0% POSITIVITY RATE, WITH ALL CYCLE NUMBERS (CN) <25. BETWEEN (B)(6) 2025, 5 POSITIVE RSV RESULTS WERE PRESENT OUT OF 240 SAMPLES INDICATING A 2.1% POSITIVITY RATE, WITH ALL CN >39. F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926208 ↗
• MalfunctionAug 29, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS ON THE RSV TARGET WHILE USING THE ALINITY M RESP-4-PLEX AMP KIT. THE FOLLOWING 5 SAMPLE IDS (SIDS) SHOWED A WEAK POSITIVE RSV RESULT AND GENERATED A NEGATIVE RESULT ON REPEAT: (B)(6). CUSTOMER PERFORMED ENVIRONMENTAL TESTING. CUSTOMER USED WET SWABS TO COLLECT SAMPLES FROM INSTRUMENT TOUCH POINTS, CENTRIFUGE, BENCHES, PIPETTES, HOODS, VORTEXES, AND SAMPLE PROCESSING AREA SINK. ALL SAMPLES WERE NEGATIVE. TECHNICAL APPLICATION SPECIALIST (TAS) REVIEWED RESULT HISTORY FOR THE PRIOR 30 DAYS. NO REACTIVE NEGATIVE QUALITY CONTROL (QC) SAMPLES ARE PRESENT. ONLY 1 INTERNAL CONTROL ERROR WAS PRESENT. 5 CELLULAR CONTROL ERRORS WERE PRESENT. 5 PIPETTING ERRORS WERE PRESENT. OVERALL COMPLETION RATE FOR THE PRIOR 30 DAYS IS 97.2%. BETWEEN 6/6/2025 - 07/06/2025 2 POSITIVE RSV RESULTS WERE PRESENT OUT OF 201 SAMPLES INDICATING A 1.0% POSITIVITY RATE, WITH ALL CYCLE NUMBERS (CN) <25. BETWEEN 7/7/2025 - 08/07/2025 5 POSITIVE RSV RESULTS WERE PRESENT OUT OF 240 SAMPLES INDICATING A 2.1% POSITIVITY RATE, WITH ALL CN >39. FALSE POSITIVE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926207 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6), (B)(6) , 2025 39.53 (B)(6), (B)(6) , 2025 41.69 (B)(6), (B)(6) , 2025 41.98 (B)(6), (B)(6) , 2025 41.62 (B)(6), (B)(6) , 2025 41.11 (B)(6), (B)(6) , 2025 41.34 (B)(6), (B)(6) , 2025 34.98 (B)(6), (B)(6) , 2025 41.65 (B)(6), (B)(6) , 2025 41.69 (B)(6), * (B)(6) , 2025 41.14 (B)(6), (B)(6) , 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822513 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6), (B)(6) , 2025 39.53 (B)(6), (B)(6) , 2025 41.69 (B)(6), (B)(6) , 2025 41.98 (B)(6), (B)(6) , 2025 41.62 (B)(6), (B)(6) , 2025 41.11 (B)(6), (B)(6) , 2025 41.34 (B)(6), (B)(6) , 2025 34.98 (B)(6), (B)(6) , 2025 41.65 (B)(6), (B)(6) , 2025 41.69 (B)(6), * (B)(6) , 2025 41.14 (B)(6), (B)(6) , 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822512 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6), (B)(6) , 2025 39.53 (B)(6), (B)(6) , 2025 41.69 (B)(6), (B)(6) , 2025 41.98 (B)(6), (B)(6) , 2025 41.62 (B)(6), (B)(6) , 2025 41.11 (B)(6), (B)(6) , 2025 41.34 (B)(6), (B)(6) , 2025 34.98 (B)(6), (B)(6) , 2025 41.65 (B)(6), (B)(6) , 2025 41.69 (B)(6), * (B)(6) , 2025 41.14 (B)(6), (B)(6) , 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822511 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6), (B)(6) , 2025 39.53 (B)(6), (B)(6) , 2025 41.69 (B)(6), (B)(6) , 2025 41.98 (B)(6), (B)(6) , 2025 41.62 (B)(6), (B)(6) , 2025 41.11 (B)(6), (B)(6) , 2025 41.34 (B)(6), (B)(6) , 2025 34.98 (B)(6), (B)(6) , 2025 41.65 (B)(6), (B)(6) , 2025 41.69 (B)(6), * (B)(6) , 2025 41.14 (B)(6), (B)(6) , 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822510 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6) (B)(6) 2025 39.53 (B)(6) (B)(6) 2025 41.69 (B)(6) (B)(6) 2025 41.98 (B)(6) (B)(6) 2025 41.62 (B)(6) (B)(6) 2025 41.11 (B)(6) (B)(6) 2025 41.34 (B)(6) (B)(6) 2025 34.98 (B)(6) (B)(6) 2025 41.65 (B)(6) (B)(6) 2025 41.69 (B)(6) (B)(6) 2025 41.14 (B)(6) (B)(6) 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION AND ENVIRONMENTAL SWABBING. INITIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822507 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6). *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION AND ENVIRONMENTAL SWABBING. INITIAL ALINITY RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. SAMPLES WERE RETESTED ON CEPHIAD, WHICH GENERATED NEGATIVE RESULTS. ALL RESULTS ARE REPORTED THROUGH INTERFACE AUTOMATICALLY AND NO QUESTIONABLE RESULTS HAVE BEEN DISCUSSED WITH PROVIDERS. THERE WAS NO REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822506 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6). *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION AND ENVIRONMENTAL SWABBING. INITIAL ALINITY RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. SAMPLES WERE RETESTED ON CEPHIAD, WHICH GENERATED NEGATIVE RESULTS. ALL RESULTS ARE REPORTED THROUGH INTERFACE AUTOMATICALLY AND NO QUESTIONABLE RESULTS HAVE BEEN DISCUSSED WITH PROVIDERS. THERE WAS NO REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822505 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6) (B)(6) 2025 39.53 (B)(6) (B)(6) 2025 41.69 (B)(6) (B)(6) 2025 41.98 (B)(6) (B)(6) 2025 41.62 (B)(6) (B)(6) 2025 41.11 (B)(6) (B)(6) 2025 41.34 (B)(6) (B)(6) 2025 34.98 (B)(6) (B)(6) 2025 41.65 (B)(6) (B)(6) 2025 41.69 (B)(6) (B)(6) 2025 41.14 (B)(6) (B)(6) 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION AND ENVIRONMENTAL SWABBING. INITIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822504 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY ON THEIR ALINITY M SYSTEM. QUESTIONED SIDS ARE LISTED BELOW, WHICH RESULTED AS POSITIVE FOR THE RSV TARGET WITH HIGH CYCLE NUMBERS. SID DATE TESTED RSV CN (CYCLE NUMBER) (B)(6), (B)(6), 2025 39.53 (B)(6), (B)(6), 2025 41.69 (B)(6), (B)(6), 2025 41.98 (B)(6), (B)(6), 2025 41.62 (B)(6), (B)(6), 2025 41.11 (B)(6), (B)(6), 2025 41.34 (B)(6), (B)(6), 2025 34.98 (B)(6), (B)(6), 2025 41.65 (B)(6), (B)(6), 2025 41.69 (B)(6), * (B)(6), 2025 41.14 (B)(6), (B)(6), 2025 41.27 *POSITIVE FOR COVID TAS REVIEWED THE RESULTS, ASSAY CONTROLS AND INTERNAL CONTROL (IC) PERFORMANCE. ALL PARAMETERS WERE PER ASSAY SPECIFICATIONS. THE AMPLIFICATION CURVES ARE VERY LATE AND LOW RISING. IC WAS AMPLIFIED AS EXPECTED. SAMPLES WITH QUESTIONABLE RESULTS HAVE BEEN PROCESSED IN SEPARATE SAMPLE RACKS FROM ASSAY CONTROLS. CURRENT TROUBLESHOOTING INCLUDES REVIEW OF ASSAY PROCESSING UNIT (APU) INVOLVED, REACTION VESSEL LOCATION, SAMPLE HANDLING, AND USE OF A FRESH AMPLIFICATION REAGENT KIT TO EXCLUDE INSTRUMENT CONTAMINATION. FIELD SERVICE ENGINEER (FSE) VISIT WAS PERFORMED FOR INSTRUMENT DECONTAMINATION AND ENVIRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22822503 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647518 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6), ON (B)(6) 2025, (41.37 CN), (B)(6), ON (B)(6) 2025, (41.31 CN), (B)(6), ON (B)(6) 2025, (36.79 CN), (B)(6), ON (B)(6) 2025, (41.28 CN), (B)(6), ON (B)(6) 2025, (37.68 CN), (B)(6), ON (B)(6) 2025, (40.68 CN), (B)(6), ON (B)(6) 2025, (41.06 CN), (B)(6), ON (B)(6) 2025, (40.69 CN), (B)(6), ON (B)(6) 2025, (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647470 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6) - (B)(6) 2025 (41.37 CN), (B)(6) - (B)(6) 2025 (41.31 CN), (B)(6) - (B)(6) 2025 (36.79 CN), (B)(6) - (B)(6) 2025 (41.28 CN), (B)(6) - (B)(6) 2025 (37.68 CN), (B)(6) - (B)(6) 2025 (40.68 CN), (B)(6) - (B)(6) 2025 (41.06 CN), (B)(6) - (B)(6) 2025 (40.69 CN), (B)(6) - (B)(6) 2025 (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647429 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6) - (B)(6) 2025 (41.37 CN). (B)(6) - (B)(6) 2025 (41.31 CN). (B)(6) - (B)(6) 2025 (36.79 CN). (B)(6) - (B)(6) 2025 (41.28 CN). (B)(6) - (B)(6) 2025 (37.68 CN). (B)(6) - (B)(6) 2025 (40.68 CN). (B)(6) - (B)(6) 2025 (41.06 CN). (B)(6) - (B)(6) 2025 (40.69 CN). (B)(6) - (B)(6) 2025 (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647423 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6) - (B)(6) 2025 (41.37 CN), (B)(6) - (B)(6) 2025 (41.31 CN), (B)(6) - (B)(6) 2025 (36.79 CN), (B)(6) - (B)(6) 2025 (41.28 CN), (B)(6) - (B)(6) 2025 (37.68 CN), (B)(6) - (B)(6) 2025 (40.68 CN), (B)(6) - (B)(6) 2025 (41.06 CN), (B)(6) - (B)(6) 2025 (40.69 CN), (B)(6) - (B)(6) 2025 (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647420 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6), ON (B)(6) 2025, (41.37 CN), (B)(6), ON (B)(6) 2025, (41.31 CN), (B)(6), ON (B)(6) 2025, (36.79 CN), (B)(6), ON (B)(6) 2025, (41.28 CN), (B)(6), ON (B)(6) 2025, (37.68 CN), (B)(6), ON (B)(6) 2025, (40.68 CN), (B)(6), ON (B)(6) 2025, (41.06 CN), (B)(6), ON (B)(6) 2025, (40.69 CN), (B)(6), ON (B)(6) 2025, (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647410 ↗
• MalfunctionJul 29, 2025False Positive Result; False Positive Result

  CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS FOR THE RSV TARGET, WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY. THE CUSTOMER IS USING A NEW LOT FOLLOWING THE RECALL BUT CONTINUES TO OBSERVE RSV RESULTS WITH CYCLE NUMBER (CN) VALUES ABOVE 40. THE CUSTOMER IS LOOKING FOR CONFIRMATION THAT THESE RESULTS ARE NOT FALSE POSITIVES. SAMPLES IN QUESTION ARE INCLUDED BELOW: (B)(6), ON (B)(6) 2025, (41.37 CN), (B)(6), ON (B)(6) 2025, (41.31 CN), (B)(6), ON (B)(6) 2025, (36.79 CN), (B)(6), ON (B)(6) 2025, (41.28 CN), (B)(6), ON (B)(6) 2025, (37.68 CN), (B)(6), ON (B)(6) 2025, (40.68 CN), (B)(6), ON (B)(6) 2025, (41.06 CN), (B)(6), ON (B)(6) 2025, (40.69 CN), (B)(6), ON (B)(6) 2025, (41.18 CN). NO SAMPLES WERE REPEATED BECAUSE EVERYTHING IS AUTO VERIFIED FOR RSV AND RESULTS WERE RELEASED AS POSITIVE. IN THE FUTURE, CUSTOMER PLANS ON IMPLEMENTING A PROCESS TO REPEAT >35 CN ON A DIFFERENT PLATFORM. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647409 ↗
• MalfunctionJul 24, 2025Unable to Obtain Readings; Unable to Obtain Readings

  CUSTOMER CALLED TO REPORT THEIR NEGATIVE CONTROL WAS REACTIVE ON MULTIPLE ATTEMPTS FOR THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588796 ↗
• MalfunctionJun 24, 2025Unable to Obtain Readings; Unable to Obtain Readings

  CUSTOMER CALLED TO REPORT THEIR NEGATIVE CONTROL WAS REACTIVE FOR THE RSV TARGET WHEN RUNNING THE ALINITY M RESP-4-PLEX ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323996 ↗