ADVIA® Chemistry LIP Lipase Reagents 10311896Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00630414482446), received between Oct 4, 2019 and Feb 13, 2020 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Imprecision” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) PATIENT AND QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA 1800 CHEMISTRY. THE INITIAL PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING AN ALTERNATE ADVIA 1800 CHEMISTRY. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707001 ↗
• MalfunctionJan 21, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA 1800 CHEMISTRY. THE CUSTOMER DID NOT INDICATE THAT PATIENT RESULTS WERE AFFECTED BY THE IMPRECISE QC ISSUE AND DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE WITH LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613268 ↗
• MalfunctionJan 21, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED MULTIPLE CALIBRATION FAILURES AND QUALITY CONTROL (QC) IMPRECISION WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA 1800 CHEMISTRY. THE CUSTOMER DID NOT INDICATE THAT PATIENT RESULTS WERE AFFECTED BY THE CALIBRATION AND QC ISSUE AND DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE WITH LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613241 ↗
• MalfunctionJan 10, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED CALIBRATION FAILURES DUE TO REAGENT BLANK LIMIT (RBL) FAILURES WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA 1800 CHEMISTRY. THE CUSTOMER DID NOT INDICATE THAT PATIENT RESULTS WERE AFFECTED BY THE CALIBRATION ISSUE THAT WAS OBSERVED IN THEIR LABORATORY WITH LIP LOT #485700. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE WITH LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575762 ↗
• MalfunctionJan 10, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED CALIBRATION FAILURES DUE TO REAGENT BLANK LIMIT (RBL) FAILURES AND IMPRECISE QUALITY CONTROL (QC) RESULTS WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA 1800 CHEMISTRY SYSTEM. THE CUSTOMER PERFORMED CALIBRATION WITH TWO DIFFERENT CALIBRATOR LOTS WHICH RESULTED IN THE SAME IMPRECISE QC. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE WITH LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575404 ↗
• MalfunctionJan 10, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED CALIBRATION FAILURES DUE TO REAGENT BLANK LIMIT (RBL) FAILURES AND IMPRECISE QUALITY CONTROL (QC) RESULTS WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA 1800 CHEMISTRY SYSTEM. THE CUSTOMER PERFORMED CALIBRATION WITH TWO DIFFERENT CALIBRATOR LOTS WHICH RESULTED IN THE SAME IMPRECISE QC. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ISSUE WITH LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575397 ↗
• MalfunctionJan 9, 2020Imprecision; Imprecision

  ON 1-DEC-2019, THE CUSTOMER OBSERVED CALIBRATION FAILURES DUE TO REAGENT BLANK LIMIT (RBL) FAILURES WHILE USING LIPASE (LIP) LOT #485700 (RECEIVED BY THE CUSTOMER ON 25-OCT-2019) WITH ADVIA 1800 CHEMISTRY SYSTEM. THE CUSTOMER USED ANOTHER PACK OF LIP LOT #485700 (RECEIVED BY THE CUSTOMER ON 29-NOV-2019) AND OBTAINED A SUCCESSFUL CALIBRATION. THE LAST REAGENT PACK WAS USED FOR PATIENT QUALITY AND CONTROL (QC) TESTING WITHOUT ISSUE. THE CUSTOMER ALLEGED THAT NO PATIENT AND QC RESULTS WERE AFFECTED BY THE INITIAL CALIBRATION ISSUE WITH LIP LOT #485700. THE CUSTOMER DID NOT PROVIDE ANY PATIENT AND QC RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE CALIBRATION ISSUE WITH THE LIP REAGENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9572017 ↗
• MalfunctionJan 9, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED IMPRECISE QUALITY CONTROL (QC) RESULTS WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA CHEMISTRY XPT SYSTEM. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS. NO INFORMATION ABOUT DISCREPANT PATIENT RESULTS WAS PROVIDED BY THE CUSTOMER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE LIP QC RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9572016 ↗
• MalfunctionJan 9, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED REAGENT BLANK LIMIT (RBL) FAILURES ON CALIBRATION WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA 1800 CHEMISTRY SYSTEM. NO QUALITY CONTROL (QC) OR PATIENT RESULTS WERE PROVIDED. IT IS UNKNOWN IF ANY SUCCESSFUL CALIBRATIONS WERE GENERATED WITH THIS REAGENT LOT. THE CUSTOMER IS NOT USING LIP LOT #485700 FOR PATIENT SAMPLE PROCESSING DUE TO THE UNACCEPTABLE PERFORMANCE OF THE CALIBRATION MATERIAL. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9571965 ↗
• MalfunctionJan 9, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED REAGENT BLANK LIMIT (RBL) FAILURES ON CALIBRATION AND IMPRECISE QUALITY CONTROL (QC) RESULTS WHILE USING LIPASE (LIP) LOT #485700 WITH ADVIA CHEMISTRY XPT. THE CUSTOMER IS NOT USING LIP LOT #485700 FOR PATIENT SAMPLE PROCESSING DUE TO THE UNACCEPTABLE PERFORMANCE OF THE QC MATERIAL AND THE IMPRECISION SEEN WHEN RUNNING A PATIENT IMPRECISION STUDY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9571961 ↗
• MalfunctionJan 9, 2020Imprecision; Imprecision

  THE CUSTOMER OBSERVED REAGENT BLANK LIMIT (RBL) FAILURES ON CALIBRATION AND IMPRECISE QUALITY CONTROL (QC) RESULTS WHILE USING LIPASE (LIP) LOT #485700 WITH 4 ADVIA 2400 CHEMISTRY SYSTEMS. THE CUSTOMER ALLEGED THAT NO PATIENT RESULTS WERE AFFECTED BY THE QC AND CALIBRATION ISSUE WITH LIP LOT #485700. THE CUSTOMER DID NOT PROVIDE ANY PATIENT RESULTS.THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9570562 ↗
• MalfunctionJan 8, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) PATIENT AND QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA CHEMISTRY XPT AND THE CUSTOMER ALSO SAW HIGH IMPRECISION FOR RBL VALUE OF CALIBRATION WITH LOT #485700. THE INITIAL AND REPEAT PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED PATIENT SERUM SAMPLES THAT WERE ALREADY RESULTED WITH PREVIOUS LIP LOTS TO ASSESS THE PRECISION OF LIP LOT 485700 ON ADVIA CHEMISTRY. THE CUSTOMER ALSO PERFORMED A LOT-TO-LOT, INSTRUMENT-TO-INSTRUMENT COMPARISON WITH BOTH QC AND PATIENT SAMPLES TO INVESTIGATE THE OBSERVED IMPRECISION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9566534 ↗
• MalfunctionJan 8, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) PATIENT AND QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA CHEMISTRY XPT AND THE CUSTOMER ALSO SAW HIGH IMPRECISION FOR RBL VALUE OF CALIBRATION WITH LOT #485700. THE INITIAL AND REPEAT PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER USED PATIENT SERUM SAMPLES THAT WERE ALREADY RESULTED WITH PREVIOUS LIP LOTS TO ASSESS THE PRECISION OF LIP LOT 485700 ON ADVIA CHEMISTRY. THE CUSTOMER ALSO PERFORMED A LOT-TO-LOT, INSTRUMENT-TO-INSTRUMENT COMPARISON WITH BOTH QC AND PATIENT SAMPLES TO INVESTIGATE THE OBSERVED IMPRECISION. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9566504 ↗
• MalfunctionJan 7, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) PATIENT AND QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA CHEMISTRY XPT. THE INITIAL PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE SAME ADVIA CHEMISTRY XPT BUT THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT CONSIDER A CORRECT LIP RESULT FOR THE SAMPLES TESTED. LIP TESTING WAS DISCONTINUED AT THE CUSTOMER SITE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559450 ↗
• MalfunctionJan 7, 2020Imprecision; Imprecision

  THE LABORATORY CONTINUES TO PROCESS LIPASE SAMPLES ACCORDING TO OUR RECOMMENDATIONS ON WORKING REAGENT BOXES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559445 ↗
• MalfunctionJan 7, 2020Imprecision; Imprecision

  THE CUSTOMER OBTAINED IMPRECISE LIPASE (LIP) PATIENT AND QUALITY CONTROL (QC) RESULTS WHILE USING ADVIA CHEMISTRY XPT. THE INITIAL PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ADVIA CHEMISTRY XPT BUT THE REPEAT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT CONSIDER A CORRECT LIP RESULT FOR THE SAMPLE TESTED. LIP TESTING WAS DISCONTINUED AT THE CUSTOMER SITE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LIP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559428 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  DISCORDANT LIPASE PATIENT RESULT WAS OBTAINED ON AN ADVIA 1800 INSTRUMENT. AFTER AN INITIAL SAMPLE WAS RUN, REPEAT SAMPLES WERE REPEATED ON THE SAME INSTRUMENT TWICE, RESULTING IN HIGHER VALUES. THE SAMPLE WAS REPEATED AGAIN THE NEXT DAY, RESULTING IN A LOWER, DISCORDANT VALUE. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). IT WAS ALLEGED THAT A MEDICAL PROCEDURE OR TREATMENT, THAT MAY HAVE BEEN UNNECESSARY, WAS PERFORMED; THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS AND EMERGENCY ROOM STAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158175 ↗