Class 2 Device Recall Atellica IM BR 27.29 (BR) assay

• Date Initiated by Firm: July 06, 2021
• Create Date: September 03, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2425-2021
• Recall Event ID: 88431
• 510(K)Number: K982680
• Product Classification: System, test, immunological, antigen, tumor - Product Code MOI
• Product: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.; SMN: 10995477
• Code Information: All lots impacted Kit lot numbers: 48553255 & 78009255 expiration date 2021-08-03, Lot number: 90311257 expiration date 2021-11-10.
• 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: Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens Healthcare issued Urgent Medical Device Correction (UMDC) via FedEx beginning on 07/06/2021. 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 07/06/2021. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Change the BR assay Pack Calibration Interval on each Atellica IM analyzer from 10 days to 3 days. See Additional Information for instructions on changing the Pack Calibration Interval. All Atellica IM BR assay kit lots can continue to be utilized with the updated Pack Calibration Interval of 3 days. Continue to follow the Atellica IM BR IFU claimed 28-day On-board Stability and 32-day Lot Calibration Intervals. 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. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Additional Information Instructions for Changing the Pack Calibration Interval on Atellica IM Analyzers Instructions for updating the BR Pack Calibration Interval from 10 days to 3 days on each Atellica IM analyzer are outlined below. 1) Sign into Atellica IM analyzer as Labmanager user level 2) In the Worklist Overview screen, move all BR results to Historical 3) In the Setup screen, select Test Definition, select IM Test Definition, and select BR Test 4) Select the Calibration Tab 5) Under Pack C
• Quantity in Commerce: 437 units
• Distribution: Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
• 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 = MOI and Original Applicant = CHIRON DIAGNOSTICS CORP.