Atellica IM Rub M 10995668Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414599830), received between Sep 15, 2023 and Sep 15, 2023 — classified as 1 malfunction.

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NEGATIVE (NONREACTIVE) ATELLICA IM RUBELLA IGM (RUBM) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. RUBM KIT LOT 211 WAS IN USE AT THE TIME. A SAMPLE FROM A PREGNANT FEMALE PATIENT WAS SENT FROM A RELATED LAB FOR CONFIRMATORY TESTING, FOLLOWING AN INITIAL POSITIVE RUBELLA IGM RESULT. ON (B)(6) 2023, THIS SAMPLE WAS TESTED USING ATELLICA IM RUBM, AND PRODUCED A NONREACTIVE (NEGATIVE) RESULT ¿ IN CONFLICT WITH THE INITIAL POSITIVE RESULT. THE SOURCE LAB ALSO SENT THE SAMPLE IN QUESTION TO AN EXTERNAL REFERENCE LAB, WHICH CONFIRMED THE INITIAL POSITIVE RESULT. THE POSITIVE RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS DUE TO THE OBSERVED DISCORDANCE. THE RESULT DISAGREEMENT WAS REPRODUCED IN LATER INVESTIGATIONAL TESTING. WHEN THE CUSTOMER RE-TESTED THE SAMPLE USING TWO ATELLICA IM INSTRUMENTS ON (B)(6) 2023, ADDITIONAL NONREACTIVE RUBM RESULTS WERE PRODUCED. THE SAMPLE WAS ADDITIONALLY TESTED USING ANOTHER ALTERNATE METHOD, AND A POSITIVE RESULT WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757172 ↗