Siemens Atellica CH Reaction Ring Cuvette Segment-has… recallZ-0496-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 21, 2024

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number

Z-0496-2025

Status

Open, Classified

Initiated by the company

Oct 21, 2024

Posted by the FDA

Nov 20, 2024

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Quantity

9729 units

Product code

JJE

FDA submissions

K161954

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 description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Atellica CH Reaction Ring Segment 11099326

  Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall23 reports

Other devices under the same FDA submission

1 device cleared under K161954 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Atellica Sample Handler Prime 11069001

  Siemens Healthcare Diagnostics Inc. · ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall1 death146 reports