Medical Device Recall: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Siemens Healthcare Diagnostics, Inc. · December 15, 2023
Reason for Recall
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
7,075 units (927 US, 6148 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1003-2024
Status: ongoing
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