Z-0496-2025Class II

Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction...

Name: Z-0496-2025 Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-10-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-10-21 / Open, Classified / root cause: packaging

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step... on 2024-10-21. FDA classified it as Class II and gives the reason as "A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0496-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-21
Posted: 2024-11-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Siemens issued Urgent Medical Device Correction (UMDC) to l US affected customers via FedEx beginning on 10/21/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers beginning on 10/21/2024. In accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Review your current Atellica CH Reaction Ring Cuvette Segment stock. All Atellica CH Reaction Ring Cuvette Segments beginning with 11 are not part of this communication and can be used without restriction. Any other lot in your stock must be immediately discarded. Locate your analyzer s serial number within the Appendix B Serial Number List. If your analyzer s serial number is in the provided list, perform the instructions in Appendix A to assess, inspect, and/or replace the Atellica CH Reaction Ring Cuvettes Segments. Determine your laboratory s replacement needs and provide detailed information to Siemens Healthineers for reporting to authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Siemens Healthineers has confirmed Atellica CH reaction ring segments beginning with lot number 11 are not impacted, and going forward all future lots will work as expected. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Quantity in commerce: 9729 units
Distribution: US Nationwide and Worldwide distribution: Foreign: Algeria Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile China Colombia Congo, Republic C¿te dIvoire Croatia Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kenya Kuwait Latvia Libya Malaysia Mexico Moldova, Rep. of Morocco Nepal Netherlands Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain Uruguay Vatikancity Vietnam
Product codes and lots: Lot # UDI N1527024 (01)00630414596143(10)N1527024(17)20291002; N1526424 (01)00630414596143(10)N1526424(17)20291001; N1525924 (01)00630414596143(10)N1525924(17)20290924 ; N1525324 (01)00630414596143(10)N1525324(17)20290918 ; N1524224 (01)00630414596143(10)N1524224(17)20290911; N1523724 (01)00630414596143(10)N1523724(17)20290904; N1523024 (01)00630414596143(10)N1523024(17)20290827; N1521824 (01)00630414596143(10)N1521824(17)20290814; N1521424 (01)00630414596143(10)N1521424(17)20290808; N1519324 (01)00630414596143(10)N1519324(17)20290719; N1518924 (01)00630414596143(10)N1518924(17)20290716; N1518224 (01)00630414596143(10)N1518224(17)20290710; N1518324 (01)00630414596143(10)N1518324(17)20290710; N1516224 (01)00630414596143(10)N1516224(17)20290621; N1515624 (01)00630414596143(10)N1515624(17)20290612; N1514924 (01)00630414596143(10)N1514924(17)20290605; N1514124 (01)00630414596143(10)N1514124(17)20290530; N1513324 (01)00630414596143(10)N1513324(17)20290522; N1512824 (01)00630414596143(10)N1512824(17)20290515; N1512424 (01)00630414596143(10)N1512424(17)20290510; N1511224 (01)00630414596143(10)N1511224(17)20290506; N1510724 (01)00630414596143(10)N1510724(17)20290423; N1510124 (01)00630414596143(10)N1510124(17)20290419.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0496-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0496-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-27	2024-11-20

Product code JJE

K161954Class IIAtellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare Diagnostics / cleared 2017-03-09

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)