Class 2 Device Recall Siemens

• Date Initiated by Firm: May 18, 2022
• Date Posted: July 06, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1340-2022
• Recall Event ID: 90387
• Product Classification: Immunoassay method, troponin subunit - Product Code MMI
• Product: Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction.; Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
• Code Information: UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 500 Gbc Dr; Newark DE 19702-2466
• For Additional Information Contact: SAME; 800-441-9250
• Manufacturer Reason for Recall: Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
• FDA Determined Cause: Under Investigation by firm
• Action: ****Recall Expanded 9-21-22*** US Customers were sent Urgent Medical Device Correction (DC-22-2.B.US) on 09/21/2022 and an Urgent Field Safety Notice UFSN DC-22-02.B.OUS) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 09/26/2022. Letter informs them to use serum patient samples only when utilizing lot BA3088. Laboratories unable to use serum patient samples for testing are to request a no charge replacement for their impacted reagent. Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 05/18/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites for distribution and regional reporting to their local competent authorities beginning on 05/18/2022. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. ¿ Siemens recommends using serum patient samples only when using the lots listed in Table 1. If your laboratory is not able to use serum samples, please discard the reagent and complete the attached Product Replacement form for a no-charge replacement product. ¿ Review your inventory to determine possible replacement needs and to provide information to Siemens for reporting to the Authorities. ¿ Complete and return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. ¿ 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.
• Quantity in Commerce: 76 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
• 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.