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Siemens Healthcare Diagnostics, Inc recalls Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer
Recalled September 15, 2021 · FDA recall Z-2424-2021 · Siemens Healthcare Diagnostics
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 · FDA Class II
Units
580 units
Sold at
Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Description
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
Product
Atellica IM BR 27.29 (BR) Assay 50 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: 10995478
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →