Atellica CH Lactate_2 (Lac_2) 11532568Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00630414287270), received between Jan 11, 2022 and Aug 7, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBSERVATION OF FALSELY DEPRESSED LACTATE_2 (LAC_2) RESULTS ON MULTIPLE PATIENT(S) SAMPLES ON ATELLICA CH ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME ATELLICA CH ANALYZER, AND THE RESULTS WERE HIGHER. THE HIGHER RESULTS WERE CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED LACTATE_2 (LAC_2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469009 ↗
• MalfunctionAug 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBSERVATION OF FALSELY DEPRESSED LACTATE 2 (LAC 2) RESULTS ON MULTIPLE PATIENT(S) SAMPLES ON ATELLICA CH ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON THE SAME ATELLICA CH ANALYZER, AND THE RESULTS WERE HIGHER. THE HIGHER RESULTS WERE CONSIDERED AS CORRECT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED LACTATE 2 (LAC 2) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469004 ↗
• MalfunctionFeb 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISCORDANT LACTATE_2 (LAC_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND AT LEAST THREE RESULTS WERE QUESTIONED. THESE THREE PATIENTS WERE REDRAWN AND THE NEW SAMPLES WERE PROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER, RESULTING HIGHER. THE CUSTOMER IS UNABLE TO PROVIDE WHETHER ADDITIONAL PATIENTS WILL BE REDRAWN AND RETESTED AND DID NOT QUANTIFY THE NUMBER OF SAMPLES IMPACTED BY THIS ISSUE. THIS MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION AS THE CUSTOMER DID NOT PROVIDE DETAILS OF ALL AFFECTED SAMPLES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LAC_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13607756 ↗
• MalfunctionJan 20, 2022Low Test Results; Low Test Results

  A FALSELY DEPRESSED LACTATE_2 (LAC_2) PATIENT SAMPLE TEST RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER USING THE ATELLICA CH LACTATE_2 (LAC_2) REAGENT. THE INITIAL TEST RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPEAT 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 THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310188 ↗
• MalfunctionJan 11, 2022Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW LACTATE_2 (LAC_2) RESULTS WERE OBTAINED ON PATIENT SAMPLES OVER A TWO DAY PERIOD ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH LACTATE_2 (LAC_2) REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LAC_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13228930 ↗
• MalfunctionJan 11, 2022Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW LACTATE_2 (LAC_2) RESULTS WERE OBTAINED ON PATIENT SAMPLES OVER A TWO DAY PERIOD ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH LACTATE_2 (LAC_2) REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LAC_2 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13228833 ↗