—#190786

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

FDA product code: JZG — System, Test, Beta-2-Microglobulin Immunological
Device class: Class 2
Medical specialty: Immunology
Affected lot / code info: Lot Number: 211446 UDI: 00630414595566

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-12-01
Terminated: 2023-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.