Class 2 Device Recall Atellica CH 2Microglobulin (B2M)

• Date Initiated by Firm: October 21, 2024
• Date Posted: December 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0599-2025
• Recall Event ID: 95666
• Product Classification: System, test, beta-2-microglobulin immunological - Product Code JZG
• Product: Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-microglobulin in human serum and plasma. Siemens Material Number (SMN): 11097635
• Code Information: UDI-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots
• 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: Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH 2-Microglobulin (B2M) reagent.
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens issued Urgent Medical Device Correction (UMDC) ACHC25-02.A.US was issued to US affected customers by FedEx beginning on 10/28/2024 and Urgent Field Safety Notice (UFSN) ACHC25-02.A.OUS. 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. " Manually dilute patient samples that are > 18.00 mg/L: 1. Navigate to the CH Test Definition screen. 2. Under Measuring Interval, uncheck Repeat when Outside Measuring Interval. 3. For samples that generate test results > 18.00 mg/L, prepare a 1:2 manual dilution with saline solution (0.9% unbuffered Isotonic saline). 4. From the Create Patient Order screen, order the sample and enter 2 in the manual dilution field on the left of the screen. Note: The system will apply the 1:2 dilution factor and calculate the final result. 5. Process the manually diluted sample. "Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. "Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution The Atellica CH B2M assay IFU will be updated with the above steps to support manual 1:2 dilution only with saline for samples > 18.00 mg/L. Please see Appendix, Table 2, for data using these revised instructions. Contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
• Quantity in Commerce: 11330 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Ivory Coast, Japan, Jordan, Kuwait, Mexico, Morocco, Oman, P.R. China, Pakistan, Paraguay, Poland, Portugal, Saudi Arabia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zaire.
• 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.