FDA-Device2024-02-14Class II
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Siemens Healthcare Diagnostics, Inc.
Hazard
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Sold states
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and PR; The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Curacao, Czech Republic, Denmark, Egypt, Estonia, Finland France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Japan, Jordan, Kenya, Kuwait, Latvia, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom, Uruguay, Vatican City, Vietnam, Zaire.
Affected count
7,075 units (927 US, 6148 OUS)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2024Don't want to check this manually?
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