—#210915

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

FDA product code: JZG — System, Test, Beta-2-Microglobulin Immunological
Device class: Class 2
Medical specialty: Immunology
Affected lot / code info: UDI-DI: 00630414595566 All in-date and future Atellica CH B2M reagent lots

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-10-21
Posted by FDA: 2024-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.