Class 2 Device Recall Atellica IM CA 199 TM Assay and ADVIA Centaur CA 199 Assay

• Date Initiated by Firm: July 26, 2024
• Date Posted: September 11, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3103-2024
• Recall Event ID: 95118
• 510(K)Number: K031393
• Product Classification: System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
• Product: ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
• Code Information: UDI-DI: (01)00630414574257(10)55970535(17)20240914; (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535, 55971535
• FEI Number: 1219913
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: same; 508-668-5000
• Manufacturer Reason for Recall: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens has issued an Urgent Medical Device Correction (UMDC) AIMC 24-14.A.US to US customers, and an Urgent Field Safety Notice (UFSN) AIMC 24-14.A.OUS to Outside the US (OUS) customers on 7/26/24. 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. " Perform the instructions provided below: o Discontinue use of and discard the kit lots listed in the table above (Products Section). o If you experience this issue, you may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. o Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. o Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution CA 19-9 kit lots ending in 535 are not available for purchase or use. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
• Distribution: Worldwide - US Nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NIG