Alinity 06R9020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740192129), received between Nov 23, 2021 and Nov 23, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2021False Positive Result; False Positive Result

  A LITERATURE ARTICLE BY SAMANTHA NGAMSUNTIKUL, JOSE QUESADA, AND RACHEL BEDDARD, ¿SARS-COV2 ANTIBODY TESTING: A COMPARISON OF TWO ASSAY PLATFORMS TO DESIGNATE CONVALESCENT PLASMA AS HIGH TITER¿, TRANSFUSION 61.SUPPL 3: 154A-155A. BLACKWELL PUBLISHING INC. (SEP 2021), DOCUMENTED A FALSE POSITIVE ALINITY I SARS-COV-2 IGG RESULT FOR ONE DONOR WHO WAS RESULTED AS NEGATIVE ON THE VITROS ASSAY. THE AIM OF THE STUDY WAS TO DETERMINE WHICH PLATFORM (ALINITY I VS VITROS) PROVIDED THE MOST UNITS THAT COULD BE DESIGNATED AS HIGH TITER FOR PATIENT USE. PER THE ARTICLE: COVID-19 CONVALESCENT PLASMA WAS DEPLOYED AS AN EARLY THERAPEUTIC WITH OUR CENTER STARTING COLLECTIONS IN APRIL OF 2020. THE FDA SUBSEQUENTLY REQUIRED THE LABELING OF THESE UNITS AS HIGH OR LOW TITER PER MINIMUM ANTIBODY CUTOFF LEVELS FOR EACH AUTHORIZED ASSAY. BECAUSE OF THE CENTER'S AFFILIATION WITH A SISTER ORGANIZATION THAT PERFORMS BLOOD AND PLASMA CENTER TESTING, WE HAD ACCESS TO TWO DIFFERENT PLATFORMS FOR QUANTITATIVE COVID-19 ANTIBODY TESTING. BETWEEN OCTOBER 2020 AND JANUARY 2021, 233 PAIRED CONVALESCENT PLASMA DONOR SAMPLES WERE TESTED FOR ANTIBODY LEVELS USING THE ANTI-SARS-COV-2 IGG ASSAY ON THE VITROS (ORTHO CLINIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863336 ↗
• MalfunctionNov 23, 2021False Negative Result; False Negative Result

  A LITERATURE ARTICLE BY SAMANTHA NGAMSUNTIKUL, JOSE QUESADA, AND RACHEL BEDDARD, ¿SARS-COV2 ANTIBODY TESTING: A COMPARISON OF TWO ASSAY PLATFORMS TO DESIGNATE CONVALESCENT PLASMA AS HIGH TITER¿, TRANSFUSION 61.SUPPL 3: 154A-155A. BLACKWELL PUBLISHING INC. (SEP 2021), DOCUMENTED FALSE NEGATIVE ALINITY I SARS-COV-2 IGG RESULTS FOR THREE DONORS WHO WERE RESULTED AS HIGH TITER ON THE VITROS ASSAY. THE AIM OF THE STUDY WAS TO DETERMINE WHICH PLATFORM (ALINITY I VS VITROS) PROVIDED THE MOST UNITS THAT COULD BE DESIGNATED AS HIGH TITER FOR PATIENT USE. PER THE ARTICLE: COVID-19 CONVALESCENT PLASMA WAS DEPLOYED AS AN EARLY THERAPEUTIC WITH OUR CENTER STARTING COLLECTIONS IN APRIL OF 2020. THE FDA SUBSEQUENTLY REQUIRED THE LABELING OF THESE UNITS AS HIGH OR LOW TITER PER MINIMUM ANTIBODY CUTOFF LEVELS FOR EACH AUTHORIZED ASSAY. BECAUSE OF THE CENTER'S AFFILIATION WITH A SISTER ORGANIZATION THAT PERFORMS BLOOD AND PLASMA CENTER TESTING, WE HAD ACCESS TO TWO DIFFERENT PLATFORMS FOR QUANTITATIVE COVID-19 ANTIBODY TESTING. BETWEEN OCTOBER 2020 AND JANUARY 2021, 233 PAIRED CONVALESCENT PLASMA DONOR SAMPLES WERE TESTED FOR ANTIBODY LEVELS USING THE ANTI-SARS-COV-2 IGG ASSAY ON THE VITROS (ORTHO C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863285 ↗