Atellica IM PRL 10995656Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00630414599748), received between Mar 30, 2021 and Dec 11, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ERRONEOUSLY DEPRESSED PROLACTIN (PRL) RESULT ON A PATIENT SAMPLE ON THE ATELLICA IM 1600 ANALYZER, WHEN USING REAGENT LOT 219. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS REPEATED TWICE ON AN ALTERNATE ATELLICA IM 1600 ANALYZER AND OBTAINED A LOWER AND HIGHER RESULT. THE SAME SAMPLE WAS REPEATED USING AN ALTERNATE TEST METHOD AND OBTAINED A HIGHER RESULT. THIS REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777897 ↗
• MalfunctionFeb 17, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ATELLICA IM PROLACTIN (PRL) PATIENT SAMPLE RESULT THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE RESULT FROM AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPOERTED TO THE PHYSICIAN AND QUESTIOINED. THE CUSTOMER REPORTED ALL RESULTS IN A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PRL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401096 ↗
• MalfunctionJan 17, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED AN ATELLICA IM PROLACTIN (PRL) RESULT WITHIN THE NON-PREGNANT FEMALE INTERVAL RANGE FOR A PATIENT THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE HIGHER RESULTS FROM AN ALTERNATE METHOD. THE PATIENT IS A NON-PREGNANT FEMALE. THE INITAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE CUSTOMER DOES NOT KNOW WHICH IS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATELLICA IM PRL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184738 ↗
• MalfunctionAug 20, 2021Low Test Results; Low Test Results

  THE CUSTOMER HAS OBSERVED A DEPRESSED RESULT FOR ONE PATIENT WHEN USING ATELLICA IM PROLACTIN (PRL), LOT 195, WHICH WAS DISCORDANT RELATIVE TO A RESULT PRODUCED USING AN ALTERNATE METHOD. 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 12347187 ↗
• MalfunctionMar 30, 2021Low Test Results; Low Test Results

  A FALSE LOW ATELLICA IM PROLACTIN (PRL) RESULT (NEAT) WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). BASED ON THE PATIENT'S CLINICAL HISTORY, A HIGHER PRL RESULT WAS EXPECTED. THE CUSTOMER PERFORMED SERIAL DILUTION TESTING OF THE SAMPLE 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 11592747 ↗