Z-0180-2022Class II

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

Name: Z-0180-2022 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2021-09-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-09-20 / Open, Classified / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543 on 2021-09-20. FDA classified it as Class II and gives the reason as "The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0180-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-20
Posted: 2021-10-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
Product code: CEK Biuret (Colorimetric), Total Protein
Reason for recall: The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.
Root cause tag: software
FDA root cause: Software design
Action: On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 1402 (US); 2941 (OUS)
Distribution: Worldwide distribution - US Nationwide distribution.
Product codes and lots: All lots impacted

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0180-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0180-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-03	2021-10-28
Z-0181-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-03	2021-10-28

Product code CEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)