BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M RESP-4-PLEX AMP KIT

    MDR report key: 23547893 · Received November 13, 2025

    Report

    Report Number
    3005248192-2025-00487
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 13, 2025
    Report Date
    January 12, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QJR
    UDI-DI
    00884999049338
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING FIELDS HAVE BEEN UPDATED: B5 FOR ADDITIONAL DETAILS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW: THE SERVER RESULT LOGS ATTACHED TO THE TICKET WERE REVIEWED WITH RESPECT TO THE REPORTED SAMPLE IDS (SIDS). THE RUNS ASSOCIATED WITH THE REPORTED SAMPLES WERE VALID, AS NO ERROR CODES ASSOCIATED WITH CONTROLS OR SAMPLES WERE GENERATED FOR THE RSV ANALYTE. THE CURVE APPEARED AS EXPECTED FOR LOW POSITIVE SAMPLES, AS THE SIGNAL WAS WEAK IN COMPARISON TO THE POSITIVE CONTROL. RETAIN/FILE SAMPLE REVIEW: THE FILE SAMPLE EVALUATION FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 WAS PERFORMED. THE FILE SAMPLE EVALUATION MET ALL VALIDITY AND ACCEPTANCE CRITERIA. THE RESULTS FOR THE PARAMETERS BEING EVALUATED WERE WITHIN THE LOWER SPECIFICATION LIMIT (LSL) AND THE UPPER SPECIFICATION LIMIT (USL). MOREOVER, THERE WERE NO INSTANCES OF FALSE POSITIVE RESULTS; THEREFORE, THE FILE SAMPLE EVALUATION FOR LOT 414709 MET THE ACCEPTANCE AND VALIDITY CRITERIA THAT WAS ESTABLISHED. AS A RESULT, THE PRODUCT FILE SAMPLE EVALUATION FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 RECEIVED A DISPOSITION OF PASS AND TESTING RESULTS DID NOT REPRODUCE THE CUSTOMER'S OBSERVATION. QUALITY DATA REVIEW: DEVICE HISTORY RECORD / BATCH RECORD REVIEW: THE MANUFACTURING PACKET FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 WAS REVIEWED TO IDENTIFY IF THERE WERE ANY ISSUES RELATED TO THE REPORTED COMPLAINT. NO ISSUES WERE IDENTIFIED WHICH COULD RESULT IN THE REPORTED COMPLAINT. THE QUALITY CONTROL (QC) AMP KIT MASTER LOT TESTING FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 MET ALL VALIDITY AND ACCEPTANCE CRITERIA. NO ISSUES RELATED TO THE REPORTED COMPLAINT WERE REPORTED DURING QC TESTING. CAPA / NON-CONFORMANCE REVIEW: A LOT SPECIFIC CAPA SEARCH WAS PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS TO THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE. LOTS 414709 AND 4147091 WERE SEARCHED. THE INVESTIGATION WAS EXPANDED TO INCLUDE THE BASE LIST PART NUMBER. A PART SPECIFIC KEYWORD SEARCH REPORT WAS PERFORMED FOR PART 9N79 TO IDENTIFY ANY EXISTING INTERNAL QUALITY RECORDS THAT COULD RESULT IN THE REPORTED COMPLAINT DURING PRODUCTION OR INTERNAL USE RECORDS THAT WERE RELATED TO THE REPORTED COMPLAINT AND PART. A PART AND KEYWORD CAPA SEARCH WAS PERFORMED TO IDENTIFY ANY RECORDS THAT ARE RELATED TO THE REPORTED COMPLAINT FOR THE PART NUMBER 09N79. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. COMPLAINT HISTORY REVIEW: A LOT SPECIFIC COMPLAINT HISTORY REVIEW WAS PERFORMED TO IDENTIFY ANY SIMILAR COMPLAINTS TO THE CASE BEING INVESTIGATE, WHICH REPORTED DISCREPANT FALSE POSITIVE RESULTS FOR THE RSV TARGET WHILE USING ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709. THE INVESTIGATION WAS EXPANDED TO INCLUDE THE PART. COMPLAINT TRENDING WAS COMPLETED. THE UPPER CONTROL LIMIT (UCL) WAS NOT EXCEEDED FOR PART 9N79. NO ADVERSE TREND WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M RESP-4-PLEX AMP KIT (LIST 09N79-090) LOT NUMBER 414709 WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M RESP-4-PLEX ASSAY, LIST LIST NUMBER 09N79-090, WHICH IS THE SAME/SIMILAR TO THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 09N79-096, WHICH RECEIVED FDA EUA APPROVAL AND THE ALINITY M RESP-4-PLEX ASSAY, LIST NUMBER 09N79-095, WHICH RECEIVED FDA APPROVAL. ADDITIONAL MDRS SUBMITTED FOR ADDITIONAL RUN DATES: 3005248192-2025-00480, 25/09/2025; 3005248192-2025-00481, 03/10/2025; 3005248192-2025-00482, 04/10/2025; 3005248192-2025-00483, 07/10/2025; 3005248192-2025-00484, 09/10/2025; 3005248192-2025-00485, 10/10/2025; 3005248192-2025-00486, 22/10/2025; 3005248192-2025-00487, 13/10/2025; 3005248192-2025-00488, 18/10/2025; 3005248192-2025-00489, 27/10/2025.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 12 FALSE POSITIVE RESULTS FOR THE RSV TARGET FOR THE PAST MONTH ON THE ALINITY M RESP-4-PLEX AMP KIT. CUSTOMER RETESTED ALL THE SAMPLES AND NONE OF THEM WERE CONFIRMED. THE FOLLOWING SAMPLE IDS (SIDS) AND CYCLE THRESHOLD (CT) RESULTS WERE PROVIDED: SID: CT: DATE: RETEST RESULT: (B)(6), 41.22 , (B)(6) 2025, NEGATIVE, (B)(6), 41.33, (B)(6) 2025, NOT RETESTED , (B)(6), 41.52 , (B)(6) 2025, GENEXPERT TRIPLEX (GXP) NEGATIVE, (B)(6), 41.65 , (B)(6)2025 , RETESTED + GXP TRIPLEX NEGATIVE ON (B)(6) 2025, (B)(6), 40.84, (B)(6)2025, NOT RETESTED, (B)(6), 40.1, (B)(6)2025, RETESTED + GXP TRIPLEX NEGATIVE ON (B)(6) 2025 , (B)(6), 41.06 , (B)(6) 2025 , NOT RETESTED, (B)(6), 40.91, (B)(6)2025 , NEGATIVE ON (B)(6) 2025, (B)(6), 41.16 , (B)(6) 2025 , NEGATIVE ON (B)(6) 2025, (B)(6), 41.17, (B)(6)2025 , NEGATIVE ON (B)(6) 2025 , (B)(6), 40.77, (B)(6)2025, NEGATIVE ON (B)(6) 2025, (B)(6), 40.76, (B)(6) 2025, NEGATIVE ON (B)(6) 2025 . THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT. ADDITIONAL INFORMATION RECEIVED 11-NOV-25: THE RESULTS WERE NOT RELEASED OUTSIDE THE LAB, AND THE CUSTOMER CONFIRMED THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 12 FALSE POSITIVE RESULTS FOR THE RSV TARGET FOR THE PAST MONTH ON THE ALINITY M RESP-4-PLEX AMP KIT. CUSTOMER RETESTED ALL THE SAMPLES AND NONE OF THEM WERE CONFIRMED. THE FOLLOWING SAMPLE IDS (SIDS) AND CYCLE THRESHOLD (CT) RESULTS WERE PROVIDED: SID CT DATE RETEST RESULT (B)(6) 41.22 (B)(6) 2025 NEGATIVE (B)(6) 41.33 (B)(6) 2025 NOT RETESTED (B)(6) 41.52 (B)(6) 2025 GENEXPERT TRIPLEX (GXP) NEGATIVE (B)(6) 41.65 (B)(6) 2025 RETESTED + GXP TRIPLEX NEGATIVE ON (B)(6) 2025 (B)(6) 40.84 (B)(6) 2025 NOT RETESTED (B)(6) 40.1 (B)(6) 2025 RETESTED + GXP TRIPLEX NEGATIVE ON (B)(6) 2025 (B)(6) 41.06 (B)(6) 2025 NOT RETESTED (B)(6) 40.91 (B)(6) 2025 NEGATIVE ON (B)(6) 2025 (B)(6) 41.16 (B)(6) 2025 NEGATIVE ON (B)(6) 2025 (B)(6) 41.17 (B)(6) 2025 NEGATIVE ON (B)(6) 2025 (B)(6) 40.77 (B)(6) 2025 NEGATIVE ON (B)(6) 2025 (B)(6) 40.76 (B)(6) 2025 NEGATIVE ON (B)(6) 2025 THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249149 ALINITY M RESP-4-PLEX AMP KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT MOLECULAR, INC. 414709 00884999049338

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown