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
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH β2-Microglobulin (B2M) Reagent Lot 211446 used for in vitro diagnostic testing to measure β2-microglobulin levels in human serum and plasma. The reagent has a bias issue affecting both quality control and patient sample results, with positive bias up to +20.9% at lower β2-microglobulin concentrations (approximately 1.5 mg/L) and negative bias up to -10.5% at higher concentrations (approximately 15 mg/L). A total of 46 units were distributed in the United States across California, Colorado, Massachusetts, Maryland, Mississippi, North Carolina, Nebraska, New Hampshire, Ohio, Virginia, and Wisconsin, while 794 units were distributed internationally across multiple countries.
The record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
¿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
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 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, Tur Quantity: US: 46 units OUS: 794 units Lot/code info: Lot Number: 211446 UDI: 00630414595566
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.