Atellica Direct Load 11068008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414002347), received between May 25, 2022 and Jun 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K151767); 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 16, 2026.

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.

• MalfunctionJun 15, 2023High Test Results; High Test Results

  A FALSELY ELEVATED HIGH-SENSITIVITY TROPONIN I (TNIH) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1300 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON TWO DIFFERENT ATELLICA IM ANALYZERS. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. THE PATIENT WAS REDRAWN, AND THE NEW SAMPLE WAS PROCESSED ON ONE OF THE LATTER ATELLICA IM ANALYZERS. THE RESULT FROM THE REDRAWN SAMPLE MATCHED THE OTHER REPEAT RESULTS. THE REPEAT RESULT OF <2.50 NG/L 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 FALSELY ELEVATED TNIH RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17137920 ↗
• MalfunctionFeb 15, 2023Computer Software Problem; Computer Software Problem

  THE CUSTOMER INFORMED SIEMENS THAT THEIR ATELLICA DIRECT LOAD (DL) INSTRUMENT RANDOMLY STOPPED THE ASPIRATION OF QUALITY CONTROL (QC) AND PATIENT SAMPLES. THE CUSTOMER NOTED THE BEHAVIOR CAUSED A DELAY IN PATIENT SAMPLE PROCESSING, AND THE PHYSICIAN(S) CALLED REQUESTING PATIENT RESULTS. THE CUSTOMER INDICATED THAT TROUBLESHOOTING WAS PERFORMED, WHICH INCLUDED A SYSTEM REBOOT AND RELOADING SAMPLES, AND THE ISSUE IS TEMPORARILY RESOLVED AND CAN RECUR. THE CUSTOMER CANNOT CONFIRM IF STAT SAMPLE TESTING WAS AFFECTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378329 ↗
• MalfunctionMay 25, 2022Optical Problem; Optical Problem

  A DELAY IN TESTING OCCURRED DUE TO A RACK BARCODE IDENTIFICATION MISREAD ERROR ON THE DIRECT LOAD (DL) MODULE OF AN ATELLICA SOLUTION. THE MISREAD ERROR CAUSED ONE TUBE TOP SAMPLING CUP (TTSC) SPECIMEN TO BE RETURNED TO THE OUTPUT LANE WITHOUT PROCESSING THE SAMPLE. NO ERROR MESSAGES WERE POSTED IN THE OPERATOR LOG ALERTING THE OPERATOR TO THE ISSUE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14501240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151767. One submission often covers many models, so check the product and lot details in each record.

• Z-2027-2025 · May 22, 2025 · Open, Classified
  Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
• Z-1003-2024 · Dec 15, 2023 · Open, Classified
  Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
• Z-0449-2022 · Nov 18, 2021 · Open, Classified
  Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. S
• Z-2026-2021 · May 13, 2021 · Open, Classified
  Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
• Z-1870-2021 · May 4, 2021 · Open, Classified
  Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
• Z-0861-2021 · Dec 2, 2020 · Terminated
  Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 - Product Usage: intended for the qualitative and quan
• Z-1797-2020 · Feb 27, 2020 · Terminated
  Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
• Z-0862-2020 · Oct 11, 2019 · Terminated
  Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed
• Z-0581-2020 · Sep 23, 2019 · Terminated
  Atellica CH 930 Analyzer
• Z-0148-2020 · Jul 30, 2019 · Terminated
  Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical
• Z-0782-2019 · Sep 26, 2018 · Terminated
  Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component s
• Z-0194-2019 · Jun 29, 2018 · Terminated
  Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.