RealTime 6L18-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884999023949), received between Aug 9, 2017 and Sep 7, 2017 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. AFTER RECEIVING URGENT FIELD SAFETY NOTICE, FA-AM-AUG2017-224, CUSTOMER FOUND 8 RE-TESTED PATIENT SAMPLES WERE DETECTED, LESS THAN 40 COPIES/ML WHICH WERE NOT CONSISTENT WITH PREVIOUSLY REPORTED "NOT DETECTED" RESULTS GENERATED WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN LINKED TO (B)(4) FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) V

  Patient problems: No Patient Involvement

  MAUDE report 6850116 ↗
• MalfunctionAug 29, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED CONTROL SAMPLES THAT WERE SUPPOSED TO HAVE HAD VIRAL LOAD RESULTS INSTEAD GAVE A (B)(6) RESULT. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AN

  Patient problems: No Patient Involvement

  MAUDE report 6828674 ↗
• MalfunctionAug 24, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (B)(6) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED FAILURE OF CALIBRATOR B WITH ERROR CODE 4457. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION 5370-ECINV AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA CAPA (B)(4) FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERNAL CONTROL ACROSS ENTIRE RUNS. REFER

  Patient problems: No Patient Involvement

  MAUDE report 6816941 ↗
• MalfunctionAug 24, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED THEY FAILED AN HIV-1 RUN OF 96 SAMPLES DUE TO ERROR CODE 4457 (INTERNAL CONTROL FAILED) ON CALIBRATOR B. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH T

  Patient problems: No Patient Involvement

  MAUDE report 6816880 ↗
• MalfunctionAug 24, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED THEY FAILED AN HIV-1 RUN OF 96 SAMPLES DUE TO INTERNAL CONTROL FAILURES ON CALIBRATOR B. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERN

  Patient problems: No Patient Involvement

  MAUDE report 6816521 ↗
• MalfunctionAug 23, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME (B)(6) ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF (B)(6) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME (B)(6) ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA (B)(6) RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. WHEN RUNNING REALTIME (B)(6), (B)(4), LOT 475933, CUSTOMER REPORTED THEY FAILED AN (B)(6) RUN OF 96 SAMPLES DUE TO INTERNAL CONTROL FAILURES ON CALIBRATOR B. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERNAL CONTROL ACROSS ENTIRE RUNS. REFER TO

  Patient problems: No Patient Involvement

  MAUDE report 6815089 ↗
• MalfunctionAug 23, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED FAILING AN HIV-1 RUN DUE TO ERROR CODE 4457 (INTERNAL CONTROL FAILED) ON THE LOW POSITIVE CONTROL. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET

  Patient problems: No Patient Involvement

  MAUDE report 6815028 ↗
• MalfunctionAug 23, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED RECEIVING ERROR CODE 4454 AND 4457 ON THEIR CALIBRATOR B SAMPLES. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERNAL CONTROL ACROSS ENTIR

  Patient problems: No Patient Involvement

  MAUDE report 6814529 ↗
• MalfunctionAug 21, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME (B)(6) ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF (B)(6) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME (B)(6) ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA (B)(6) RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. WHEN RUNNING REALTIME (B)(6), (B)(4), LOT 475933, CUSTOMER REPORTED HIGH POSITIVE CONTROL AND LOW POSITIVE CONTROLS RUNNING AT THE TOP OF THE ALLOWABLE RANGE. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERNAL CONTROL ACROSS ENTIRE RUNS. REFER TO

  Patient problems: No Patient Involvement

  MAUDE report 6808958 ↗
• MalfunctionAug 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTIONPOLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF (B)(6), ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA (B)(6) LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED FAILURES OF CALIBRATOR B DUE TO ERROR CODE 4457 ON INTERNAL CONTROL. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4) FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH TARGET AND INTERNAL CONTROL ACROSS ENTIRE RUNS. THE MEDICAL EVALUATION CONCLUD

  Patient problems: No Patient Involvement

  MAUDE report 6796180 ↗
• MalfunctionAug 15, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. WHEN RUNNING REALTIME HIV-1, LIST 06L18-90, LOT 475933, CUSTOMER REPORTED FAILURES OF CALIBRATOR B AND THEN AFTER TROUBLESHOOTING, EXPERIENCED FAILURE OF THE HIGH POSITIVE CONTROL. COMPLAINT TICKET HAS BEEN REVIEWED VIA ELEVATED COMPLAINT INVESTIGATION (B)(4) AND HAS BEEN DETERMINED TO BE THE SAME ISSUE AS PREVIOUSLY CONFIRMED VIA (B)(4)CAPA FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES FOR BOTH

  Patient problems: No Patient Involvement

  MAUDE report 6795152 ↗
• MalfunctionAug 9, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ABBOTT REALTIME HIV-1 ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF (B)(6) ON THE AUTOMATED M2000 SYSTEM IN HUMAN PLASMA FROM (B)(6) INFECTED INDIVIDUALS OVER THE RANGE OF 40 TO 10,000,000 COPIES/ML. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS FOR DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA (B)(6) LEVELS. THIS ASSAY IS NOT INTENDED TO BE USED AS A DONOR SCREENING TEST FOR (B)(6) OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF (B)(6) INFECTION. A CUSTOMER COMPLAINT FROM (B)(6) WAS RECEIVED INDICATING RECEIPT OF ERROR CODES RELATED TO NON-US LIST 02G31-010 LOT 476139. BASED ON REVIEW OF CUSTOMER RUN DATA AND INTERNAL TESTING, THE COMPLAINT INVESTIGATION WAS CONFIRMED FOR REDUCED PCR AMPLIFICATION EFFICIENCY, WHICH PRESENTS AS DELAYED THRESHOLD CYCLE (CT) VALUES AND REDUCED MAX RATIO (MR) VALUES. ON JUNE 22, 2017, THIS CUSTOMER COMPLAINT FROM THE UNITED STATES WAS RECEIVED. CUSTOMER INDICATED ERROR CODE GENERATION AND NON-ABBOTT CONTROLS COMING UP NOT DETE

  Patient problems: No Patient Involvement

  MAUDE report 6779184 ↗