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Siemens Healthcare Diagnostics, Inc Recall 88431

Description: 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

Siemens Healthcare Diagnostics, Inc Recall 88431 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2424-2021
Event ID88431
Event DescriptionAtellica 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
Product TypeDevices
DistributionWorldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Quantity580 units
Recall ReasonProduct 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
Device Classification20210915
Device Code InfoAll lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
Center Classification Date20210903
Recall Initiation Date20210706
Recalling FirmSiemens Healthcare Diagnostics, Inc
Initial Notification Letter
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