Atellica IM PTH 10995622Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00630414599458), received between Mar 25, 2020 and Jan 17, 2024 — classified as 5 malfunctions.

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

• MalfunctionJan 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANT ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS ON MULTIPLE PATIENT(S) SAMPLES ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. ALL THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZERS AND THE RESULTS WERE LOWER COMPARED TO THE INITIAL RESULTS. THESE RESULTS WERE CONSIDERED AS CORRECT RESULTS BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530630 ↗
• MalfunctionJan 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF A DISCORDANT ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULT ON A PATIENT SAMPLE ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THIS SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM 1600 ANALYZER AND THE RESULT WAS LOWER COMPARED TO THE INITIAL RESULT. THIS RESULT WAS CONSIDERED AS THE CORRECT RESULT BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530426 ↗
• MalfunctionJan 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANT ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS ON MULTIPLE PATIENT(S) SAMPLES ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. ALL THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZERS AND THE RESULTS WERE LOWER COMPARED TO THE INITIAL RESULTS. THESE RESULTS WERE CONSIDERED AS CORRECT RESULTS BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530403 ↗
• MalfunctionJan 17, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED AN OBSERVATION OF DISCORDANT ELEVATED INTACT PARATHYROID HORMONE (PTH) RESULTS ON MULTIPLE PATIENT(S) SAMPLES ON ATELLICA IM 1600 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. ALL THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZERS AND THE RESULTS WERE LOWER COMPARED TO THE INITIAL RESULTS. THESE RESULTS WERE CONSIDERED AS CORRECT RESULTS BY THE PHYSICIAN(S). A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530121 ↗
• MalfunctionMar 25, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A DISCORDANT LOW RESULT WAS OBSERVED ON AN ATELLICA IM INTACT PARATHYROID HORMONE (PTH) SAMPLE THAT HAD BEEN PREVIOUSLY FROZEN AT -24 C. THE SAMPLE WAS REPEATED THE FOLLOWING DAY AFTER CENTRIFUGATION RESULTING HIGHER. THE HIGHER RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT PTH RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9878861 ↗