Atellica IM CHIV 10995459Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414600390), received between Sep 8, 2022 and Jan 8, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED DISCORDANT FALSE NEGATIVE (NON-REACTIVE) HIV AG/AB COMBO (CHIV) LOT 344 RESULTS ON SAMPLES FROM A KNOWN POSITIVE HIV-1 PATIENT WHEN PROCESSED ON AN ATELLICA IM 1300 ANALYZER (S/N: (B)(6) ). THE INITIAL TESTING WAS PERFORMED ON AN ALTERNATE METHOD THAT RESULTED POSITIVE (REACTIVE). THE SAME SAMPLE (SERUM) WAS TESTED WITH ATELLICA IM CHIV LOT 344, AND A NEGATIVE (NON-REACTIVE) DISCORDANT RESULT WAS OBTAINED. A DIFFERENT SAMPLE (PLASMA) WAS OBTAINED AND WAS ALSO TESTED IN 2 REPLICATES WITH ATELLICA IM CHIV LOT 344. ONE RESULT WAS NEGATIVE (NON-REACTIVE) AND ONE RESULT WAS POSITIVE (REACTIVE). BOTH SERUM AND PLASMA SAMPLES WERE RETESTED ON THE ALTERNATE METHOD, AND BOTH RESULTED AS POSITIVE (REACTIVE) RESULT. BOTH SERUM AND PLASMA SAMPLES WERE TESTED ON A DIFFERENT ALTERNATE METHOD AND WERE CONFIRMED POSITIVE (REACTIVE). THE ATELLICA IM CHIV NEGATIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE PATIENT WAS REPORTED OUT AS POSITIVE, WHICH IS CONSISTENT WITH PATIENT HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NEGATIVE CHIV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471099 ↗
• MalfunctionJan 8, 2024False Negative Result; False Negative Result

  THE CUSTOMER OBTAINED DISCORDANT FALSE NEGATIVE (NON-REACTIVE) HIV AG/AB COMBO (CHIV) LOT 344 RESULTS ON SAMPLES FROM A KNOWN POSITIVE HIV-1 PATIENT WHEN PROCESSED ON AN ATELLICA IM 1300 ANALYZER (S/N: (B)(6) ). THE INITIAL TESTING WAS PERFORMED ON AN ALTERNATE METHOD THAT RESULTED POSITIVE (REACTIVE). THE SAME SAMPLE (SERUM) WAS TESTED WITH ATELLICA IM CHIV LOT 344, AND A NEGATIVE (NON-REACTIVE) DISCORDANT RESULT WAS OBTAINED. A DIFFERENT SAMPLE (PLASMA) WAS OBTAINED AND WAS ALSO TESTED IN 2 REPLICATES WITH ATELLICA IM CHIV LOT 344. ONE RESULT WAS NEGATIVE (NON-REACTIVE) AND ONE RESULT WAS POSITIVE (REACTIVE). BOTH SERUM AND PLASMA SAMPLES WERE RETESTED ON THE ALTERNATE METHOD, AND BOTH RESULTED AS POSITIVE (REACTIVE) RESULT. BOTH SERUM AND PLASMA SAMPLES WERE TESTED ON A DIFFERENT ALTERNATE METHOD AND WERE CONFIRMED POSITIVE (REACTIVE). THE ATELLICA IM CHIV NEGATIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE PATIENT WAS REPORTED OUT AS POSITIVE, WHICH IS CONSISTENT WITH PATIENT HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NEGATIVE CHIV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18471063 ↗
• MalfunctionSep 8, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A POSITIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT FOR A 49-YEAR-OLD FEMALE PATIENT THAT WAS NEGATIVE UPON CONFIRMATION TESTING WITH AN ALTERNATE TEST METHOD. THE CUSTOMER ALLEGED THAT THE PATIENT WAS DENIED KIDNEY TRANSPLANT BASED ON THE POSITIVE CHIV SCREENING RESULT. THE CUSTOMER STATED THAT THE NEGATIVE CONFIRMATORY RESULT ON THE ALTERNATE TEST METHOD WAS A SEND OUT SO TOOK A WEEK FOR FINAL RESULT. THIS SAME PATIENT WAS TESTED APPROXIMATELY 7 MONTHS LATER AND A POSITIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED AGAIN, AND THE ALTERNATE METHOD CONFIRMATORY TESTING WAS NEGATIVE AGAIN. THERE ARE NO REPORTS BY THE CUSTOMER OF ADVERSE HEALTH CONSEQUENCES DUE TO DISCORDANT CHIV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386996 ↗
• MalfunctionSep 8, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A POSITIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT FOR A 49-YEAR-OLD FEMALE PATIENT THAT WAS NEGATIVE UPON CONFIRMATION TESTING WITH AN ALTERNATE TEST METHOD. THE CUSTOMER ALLEGED THAT THE PATIENT WAS DENIED KIDNEY TRANSPLANT BASED ON THE POSITIVE CHIV SCREENING RESULT. THE CUSTOMER STATED THAT THE NEGATIVE CONFIRMATORY RESULT ON THE ALTERNATE TEST METHOD WAS A SEND OUT SO TOOK A WEEK FOR FINAL RESULT. THIS SAME PATIENT WAS TESTED APPROXIMATELY 7 MONTHS LATER AND A POSITIVE ATELLICA IM HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED AGAIN, AND THE ALTERNATE METHOD CONFIRMATORY TESTING WAS NEGATIVE AGAIN. THERE ARE NO REPORTS BY THE CUSTOMER OF ADVERSE HEALTH CONSEQUENCES DUE TO DISCORDANT CHIV RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386774 ↗