Atellica CH TBil_2 11097531Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414595818), received between Oct 21, 2021 and Sep 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

2 FDA recall records name this device's identifier, 1 still open.

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. Jul 10, 2023Class IIOpen, Classified

   Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC)

   Z-2471-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Feb 13, 2020Class IITerminated

   Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

   Z-1537-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionSep 13, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) NEONATE PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT AS THE NEONATE HAD JAUNDICE. A SECOND (DIFFERENT) SAMPLE WAS PROCESSED ON AN ALTERNATE SIEMENS METHODOLOGY (RP500E BLOOD GAS ANALYZER). A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216906 ↗
• MalfunctionJun 23, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBTAINED A FALSELY DEPRESSED TOTAL BILIRUBIN_2 (TBIL_2) RESULT ON A NEWBORN CHILD PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE ORIGINAL ATELLICA CH INSTRUMENT AND AGAIN REPEATED ON AN ALTERNATE ATELLICA CH INSTRUMENT. THE REPEAT RESULTS RECOVERED HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULTS WERE REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS TBIL_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189476 ↗
• MalfunctionOct 21, 2021Low Test Results; Low Test Results

  A DISCORDANT, FALSELY LOW TOTAL BILIRUBIN_2 (TBIL_2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH TOTAL BILIRUBIN_2 REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR TBIL_2 ON AN ALTERNATE ATELLICA CH 930 ANALYZER ALSO USING TOTAL BILIRUBIN_2 REAGENT, RECOVERING HIGHER. THE HIGHER RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW TBIL_2 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675137 ↗