medical Class II Updated 2021-09-15

Siemens Healthcare Diagnostics, Inc recalls Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in

Recalled Product

Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- 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: 11206236

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.
View official government recall

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