Class 2 Device Recall Siemens

• Date Initiated by Firm: April 21, 2021
• Create Date: May 24, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1674-2021
• Recall Event ID: 87770
• 510(K)Number: K112343
• Product Classification: Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
• Product: Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
• Code Information: All Lots
• 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: Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This carryover effect only occurs when the impacted assays are used immediately following testing with the Syphilis assay on the ADVIA Centaur XP/XPT or ADVIA Centaur CP systems
• FDA Determined Cause: Device Design
• Action: Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers via FedEx beginning on 04/21/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 04/21/2021. Letter states reason for recall, health risk and Actions to be Taken by the Customer: Please review this letter with your Medical Director. ¿ If you have multiple ADVIA Centaur XP/XPT or ADVIA Centaur CP systems: ¿ Siemens recommends testing the ADVIA Centaur Syphilis assay on a separate system from the impacted ADVIA Centaur assays (ADVIA Centaur PRGE, T4 on the ADVIA Centaur XP/XPT and ADVIA Centaur AFP, COR, PHTN, VALP on the ADVIA Centaur CP) to avoid the potential carryover effect. ¿ If you have a single ADVIA Centaur XP/XPT or ADVIA Centaur CP system: ¿ It is important to prevent the impacted assays from being processed after the Syphilis assay without a Daily Cleaning Procedure (DCP) run in between. For example, this can be achieved by processing all Syphilis testing, running the DCP, and then proceeding with all other testing including the impacted assays. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
• Quantity in Commerce: 22550 units
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Burkina Faso, Croatia, Czech Republic, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, Germany, Greece, Guadeloupe, Italy, Kazakhstan, Latvia, Netherlands, Norway, Poland, Portugal, Qatar, Russian Fed., Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., Ukraine, United Kingdom.
• 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 = LIP and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.