Atellica CH CHEM Calibrator 11099411Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414597492), received between Feb 26, 2021 and Apr 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 5, 2020Class IITerminated

   Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

   Z-2431-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED LOW CALCIUM_2 (CA_2) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE CUSTOMER RECALIBRATED THE ASSAY AND REPEATED SIX PATIENT SAMPLES. THE REPEAT RESULTS RECOVERED HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). WHILE TWELVE OTHER PATIENT SAMPLES RECOVERED LOW, THESE SAMPLES WERE NOT AVAILABLE FOR REPEAT TESTING. THE RESULTS FOR THESE TWELVE SAMPLES WERE INCLUDED IN THIS REPORT IN AN ABUNDANCE OF CAUTION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW CA_2 PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14242065 ↗
• MalfunctionFeb 26, 2021High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CALCIUM (CA_2) PATIENT RESULTS WERE OBTAINED ON 7 DIFFERENT ATELLICA CH 930 ANALYZERS FOLLOWING CALIBRATION WITH CHEMISTRY CALIBRATOR (CHEM CAL) LOT 993626. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE PATIENTS HAVE HAD A CHANGE IN MEDICATION OR HAD TO RECEIVE ADDITIONAL BLOOD TESTS DUE TO THE DISCORDANT CA_2 RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385956 ↗