ADVIA® Chemistry Calibrator 10312279Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414223414), received between Apr 12, 2018 and Dec 29, 2020 — classified as 3 malfunctions.

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

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K050374); 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.

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-2430-2020 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionDec 29, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CALCIUM_2 CONCENTRATED (CA_2C) PATIENT RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM FOLLOWING CALIBRATION WITH CHEMISTRY CALIBRATOR (CHEM CAL) LOT 993624. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE NOT REPEATED, AND PATIENTS WERE SENT TO THE HOSPITAL TO HAVE A NEW BLOOD SAMPLE DRAWN TO MEASURE FREE CALCIUM. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CA_2C RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11091156 ↗
• MalfunctionApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY DEPRESSED CREATININE (ENZYMATIC METHOD) RESULT WAS OBTAINED ON THE ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (ECRE_2) ASSAY. THE DISCORDANT RESULT WAS OBTAINED WITH A NEW LOT OF ADVIA CHEMISTRY CALIBRATOR. THE DISCORDANT RESULT WAS NOT IN ALIGNMENT WITH THE PREVIOUS RESULT FROM THIS SAMPLE. IT IS NOT KNOWN IF THE DISCORDANT RESULT WAS REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE DISCORDANT CREATININE RESULT. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENT DUE TO THE DISCORDANT CREATININE RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426998 ↗
• MalfunctionApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY DEPRESSED CREATININE (ENZYMATIC METHOD) RESULTS WERE OBTAINED ON THE ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (ECRE_2) ASSAY. THE DISCORDANT RESULT WAS OBTAINED AFTER THE ASSAY WAS CALIBRATED USING A NEW LOT OF CALIBRATOR. THE DISCORDANT RESULTS WAS NOT IN ALIGNMENT WITH PREVIOUS RESULTS OF THE SAMPLES. IT IS NOT KNOWN IF ANY OF THE DISCORDANT RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION DUE TO THE DISCORDANT CREATININE RESULTS. THERE ARE NO KNOWN REPORTS OF A DELAY IN ADMINISTERING TREATMENT OR MEDICAL INTERVENTION TO THE PATIENTS DUE TO THE DISCORDANT CREATININE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426996 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050374. One submission often covers many models, so check the product and lot details in each record.

• Z-0104-2023 · Sep 19, 2022 · Open, Classified
  Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
• Z-0105-2023 · Sep 19, 2022 · Open, Classified
  Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
• Z-0931-2022 · Feb 9, 2022 · Open, Classified
  Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
• Z-0589-2017 · Oct 7, 2016 · Terminated
  Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the following methods: Albumin (ALB, ALB_c), Direct Bilirubin (DBIL_2), To
• Z-0365-2014 · Sep 24, 2013 · Terminated
  Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD Pr