Atellica CH AlbP 11097530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414595825), received between Dec 27, 2024 and Dec 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED ALBUMIN BCP (ALBP) RESULTS ON THREE (3) PATIENT SAMPLES WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. TWO OF THE PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED ALBUMIN BCP (ALBP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029236 ↗

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 clini
• 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.