Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

• • Ongoing Z-2027-2025 FDA Class II ·initiated 22 May 2025 ·on shared 510(k) K151767

  Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

• • Ongoing Z-0597-2025 FDA Class II ·initiated 4 Nov 2024 ·on shared 510(k) K222116

  Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.

• • Ongoing Z-1003-2024 FDA Class II ·initiated 15 Dec 2023 ·on shared 510(k) K151767

  Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

• • Ongoing Z-0449-2022 FDA Class II ·initiated 18 Nov 2021 ·on shared 510(k) K151767

  (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

• • Ongoing Z-2026-2021 FDA Class II ·initiated 13 May 2021 ·on shared 510(k) K151767

  Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.

• • Ongoing Z-1870-2021 FDA Class II ·initiated 4 May 2021 ·on shared 510(k) K151767

  Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results

• • Terminated Z-0861-2021 FDA Class II ·initiated 2 Dec 2020 ·on shared 510(k) K151767

  Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

• • Terminated Z-1797-2020 FDA Class II ·initiated 27 Feb 2020 ·on shared 510(k) K151767

  Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings of the assay s test definition, and Auto-Rerun or Auto-Dilution results may generate a result of Zero (0) for quantitative assays or Negative for qualitative assays if a well of the reagent pack is not calibrated.

• • Terminated Z-0862-2020 FDA Class II ·initiated 11 Oct 2019 ·on shared 510(k) K151767

  On the Atellica CH 930 Analyzer, when scanning barcodes at the module console for Integrated Multisensor Technology (IMT) system fluids (Standard A (Std A) and Standard B (Std B)) for Sodium (Na), Potassium (K), and Chloride (Cl), the system will translate the decimal point separators to commas. This will result in invalid concentration values for the fluids, therefore the system will utilize default nominal values instead of lot specific IMT fluid concentration values for calculation of the calibrations and results for the Na, K, and Cl methods.

• • Terminated Z-0581-2020 FDA Class II ·initiated 23 Sep 2019 ·on shared 510(k) K151767

  Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

• • Terminated Z-0148-2020 FDA Class II ·initiated 30 Jul 2019 ·on shared 510(k) K151767

  Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

• • Terminated Z-0782-2019 FDA Class II ·initiated 26 Sep 2018 ·on shared 510(k) K151767

  Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer; Atellica Sample Handler Prime

• • Terminated Z-0194-2019 FDA Class II ·initiated 29 Jun 2018 ·on shared 510(k) K151767

  Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Atellica CH Albumin BCP (AlbP) EUDAMED

Atellica CH AlbP GUDID

Generic Name

Albumin IVD, kit, spectrophotometry

Device Name

IVDR_67_TTN_DUB-C_b_reag_albp

Model / Ref / Catalog

11097530, IVDR_67_TTN_DUB-C_B_REAG_ALBP

Primary DI / UDI-DI

00630414595825

Basic UDI-DI

0405686900760VQ

Unit of Use DI

00630414006871

510(k) Number

K222116 ↗ 510(k)

K151767 ↗ GUDID

FDA Product Code

JLW 510(k)

CJW GUDID

EMDN Code

W01010201 Albumin (cc)

GMDN Term

Albumin IVD, kit, spectrophotometry

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 862.1690 510(k)

862.1035 GUDID

EU market of registration

Germany

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Atellica CH Acetaminophen 2 (ACTM)

  Class II

  FDA 510(k) K261364 Active Cleared 24 Jul 2026

• Labstix

  Class B

  CE/IVDR IX 1290554-8 Active Valid to Jun 2028

• Atellica IM CA 19-9 II

  Class II

  FDA 510(k) K253528 Active Cleared 10 Aug 2026

• Atellica IM Lipopolysaccharide Binding Protein (LBP)

  Class C

  CE/IVDR

• Atellica CH Cannabinoids (ThcC)

  Class B

  CE/IVDR GUDID on market

• Atellica CH Cholesterol_2 (Chol_2)

  Class B

  CE/IVDR

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