Atellica IM Rub G 10995670Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414600529), received between Oct 14, 2020 and Dec 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (4 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.

• MalfunctionDec 18, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE (POSITIVE) ATELLICA IM RUBELLA IGG (RUB G) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. RUB G KIT LOT 247 WAS IN USE AT THE TIME. THE CUSTOMER OBSERVED REACTIVE RUB G RESULTS FOR ONE PATIENT WHICH WERE CONSIDERED FALSELY POSITIVE. THE PATIENT IN QUESTION WAS INITIALLY TESTED IN (B)(6), AND PRODUCED AN EQUIVOCAL RUB G RESULT WHEN TESTED WITH ATELLICA IM RUB G, LOT 243. NO ADDITIONAL TESTING IS DESCRIBED FOR THAT TIME PERIOD. THE SAME PATIENT WAS TESTED AGAIN IN (B)(6), USING RUB G KIT LOT 247. THE RESULT FOR THIS SECOND SAMPLE WAS REACTIVE (POSITIVE). AS THIS REACTIVE RESULT WAS CONSIDERED QUESTIONABLE, THE PATIENT¿S EARLIER (EQUIVOCAL) SAMPLE FROM (B)(6) WAS RE-TESTED TO INVESTIGATE. THIS SAMPLE, WHICH HAD EARLIER PRODUCED AN EQUIVALENT RESULT WITH THE EARLIER KIT LOT, NOW GAVE A REACTIVE RESULT WHEN TESTED WITH RUB G LOT 247, INDICATING THAT THIS PATIENT WAS REPRODUCIBLY REACTIVE. BOTH SAMPLES FROM THIS PATIENT (B)(6) WERE SENT TO AN EXTERNAL LAB, AND TESTED BY AN ALTERNATE METHOD. BOTH SAMPLES RETURNED NEGATIVE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345514 ↗
• MalfunctionFeb 11, 2022False Positive Result; False Positive Result

  CUSTOMER OBSERVED FALSE REACTIVE (POSITIVE) ATELLICA IM RUBELLA IGG (RUB G) RESULT FROM A SAMPLE THAT WAS CONSIDERED DISCORDANT UPON COMPARISON WITH REPEAT RESULTS FROM THE SAME SAMPLE. THE PREVIOUS RESULT FOR THE PATIENT WAS NONREACTIVE (NEGATIVE). RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS THAT TREATMENT WAS ALTERED OR POSTPONED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE REACTIVE ATELLICA IM RUB G RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13513415 ↗
• MalfunctionOct 14, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED A REACTIVE (POSITIVE) RESULT ON A PATIENT SAMPLE USING ATELLICA IM RUBELLA IGG (RUB G). THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS OBTAINED AND TESTED ON A DIFFERENT DAY ON THE SAME INSTRUMENT AND A REACTIVE (POSITIVE) RESULT WAS AGAIN OBTAINED. THE SAMPLE WAS THEN TESTED AT TWO NON-CUSTOMER LABORATORY SITES FOR TESTING WITH ALTERNATE METHODS. A NON REACTIVE (NEGATIVE) RESULT WAS OBTAINED AT EACH NON-CUSTOMER LABORATORY SITE. THE CUSTOMER BELIEVES THE NON-REACTIVE (NEGATIVE) RESULTS TO BE CORRECT. A CORRECTED REPORT WAS NOT PROVIDED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE (POSITIVE) ATELLICA IM RUB G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10679983 ↗
• MalfunctionOct 14, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED A REACTIVE (POSITIVE) RESULT ON A PATIENT SAMPLE USING ATELLICA IM RUBELLA IGG (RUB G). THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS OBTAINED AND TESTED ON A DIFFERENT DAY ON THE SAME INSTRUMENT AND A REACTIVE (POSITIVE) RESULT WAS AGAIN OBTAINED. THE SAMPLE WAS THEN TESTED AT TWO NON-CUSTOMER LABORATORY SITES FOR TESTING WITH ALTERNATE METHODS. A NON REACTIVE (NEGATIVE) RESULT WAS OBTAINED AT EACH NON-CUSTOMER LABORATORY SITE. THE CUSTOMER BELIEVES THE NON-REACTIVE (NEGATIVE) RESULTS TO BE CORRECT. A CORRECTED REPORT WAS NOT PROVIDED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE (POSITIVE) ATELLICA IM RUB G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10679958 ↗