FDA-Device2021-09-15Class II
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Siemens Healthcare Diagnostics, Inc
Hazard
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
Sold states
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Affected count
437 units
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995477
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2021Don't want to check this manually?
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