Atellica IM PRL 10995655Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414599731), received between Dec 4, 2020 and Nov 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2021Low Test Results; Low Test Results

  A CUSTOMER OBSERVED A LOW ATELLICA IM PROLACTIN (PRL) RESULT ON 2 DIFFERENT SAMPLES TAKEN FROM THE SAME PATIENT. THE DEPRESSED RESULTS ARE CONSIDERED DISCORDANT COMPARED TO ALTERNATE METHOD TESTING RESULTS AND PATIENT CLINICAL HISTORY. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A CORRECTED REPORT HAS NOT BEEN ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROLACTIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753598 ↗
• MalfunctionNov 4, 2021Low Test Results; Low Test Results

  A CUSTOMER OBSERVED A LOW ATELLICA IM PROLACTIN (PRL) RESULT ON 2 DIFFERENT SAMPLES TAKEN FROM THE SAME PATIENT. THE DEPRESSED RESULTS ARE CONSIDERED DISCORDANT COMPARED TO ALTERNATE METHOD TESTING RESULTS AND PATIENT CLINICAL HISTORY. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A CORRECTED REPORT HAS NOT BEEN ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROLACTIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753597 ↗
• MalfunctionDec 4, 2020Low Test Results; Low Test Results

  A FALSE LOW ATELLICA IM PROLACTIN (PRL) RESULT WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) TESTING OF THE SAMPLE, RESULTING LOW. FURTHER SAMPLE DILUTIONS WERE PERFORMED AND THE PRL RESULTS INCREASED AS THE DILUTION FACTOR INCREASED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ATELLICA IM PROLACTIN (PRL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946377 ↗