Siemens Atellica Cuvette Segment (Siemens) – Manufacturing Defect (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.