Class 2 Device Recall Siemens

• Date Initiated by Firm: December 01, 2021
• Create Date: December 29, 2021
• Recall Status: Terminated on July 07, 2023
• Recall Number: Z-0440-2022
• Recall Event ID: 89211
• Product Classification: System, test, beta-2-microglobulin immunological - Product Code JZG
• Product: Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635
• Code Information: Lot Number: 211446 UDI: 00630414595566
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: SAME; 914-631-8000
• Manufacturer Reason for Recall: 2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens issued An Urgent Medical Device Correction (UMDC) letter to US customers by FedEx beginning on 2021-12-01. 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 2021-12-01. Letter states reason for recall, health risk and action to take: Discontinue use of and discard the kit lot listed in Table 1. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director. 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 product 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, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
• Quantity in Commerce: US: 46 units OUS: 794 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France, Germany, Greece, India, Iran, Israel, Italy, Japan, Mexico, Morocco, Oman, P.R. China, Pakistan, Philippines, Portugal, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom, Uruguay.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.