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Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in h
Recalled December 11, 2024 · FDA recall Z-0599-2025 · Siemens Healthcare Diagnostics
Hazard
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 Class II
Units
11330 units
Sold at
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.
Description
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.
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
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →