ADVIA® Chemistry IGM_2 Reagents 10309032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414513126), received between Jul 20, 2017 and Sep 1, 2017 — classified as 2 malfunctions.

1 other recall cover devices cleared under the same FDA submission (K992662); they may or may not involve this specific model.

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

• MalfunctionSep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A DISCORDANT, FALSELY LOW IMMUNOGLOBULIN M_2 (IGM_2) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE WHEN RUN NEAT ON AN ADVIA 2400 INSTRUMENT, WHILE USING REAGENT LOT 411515. ON (B)(6) 2017, THE SAMPLE WAS ANALYZED USING AN ALTERNATE METHODOLOGY, RESULTING HIGH AND INDICATIVE OF HIGH PARAPROTEIN BAND. THE CUSTOMER CONFIRMED THE HIGH RESULT BY REPEATING THE SAMPLE ON THE ALTERNATE METHODOLOGY. THIS PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE AS NEAT AND WITH DILUTION ON THE ADVIA 2400 INSTRUMENT. THIS IS WHEN THE CUSTOMER DETERMINED THAT THE NEAT RESULTS AND A RESULT OBTAINED UPON INITIAL DILUTION ON THE ADVIA 2400 INSTRUMENT WERE DISCORDANT. THE RESULTS FROM THE ELECTROPHORESIS AND THE RESULTS OBTAINED ON THE ADVIA 2400 INSTRUMENT UPON MANUAL DILUTION WERE CONSIDERED CORRECT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGM_2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6838417 ↗
• MalfunctionJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW IMMUNOGLOBULIN M_2 (IGM_2) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE WHEN RUN NEAT ON AN ADVIA 2400 INSTRUMENT, WHILE USING REAGENT LOT 411515. THE SAMPLE WAS MANUALLY DILUTED WITH 1:10 DILUTION FACTOR AND REPEATED TWICE IN DUPLICATE ON THE SAME INSTRUMENT, RESULTING HIGHER EACH TIME. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW IGM_2 RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727816 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992662. One submission often covers many models, so check the product and lot details in each record.

• Z-1003-2024 · Dec 15, 2023 · Open, Classified
  Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry