Siemens Healthcare Diagnostics, Inc 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Siemens Healthcare Diagnostics, Inc
Lot Codes / Batch Numbers
All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
Products Sold
All lots impacted. Kit lot numbers: 40476255 & 64505255 expiration date 2021-08-03, Lot numbers: 89332257 & 05694257 expiration date 2021-11-10.
Siemens Healthcare Diagnostics, Inc is recalling Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial det due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Siemens Healthcare issued Urgent Medical Device Correction (UMDC) via FedEx beginning on 07/06/2021. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities beginning on 07/06/2021. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Change the BR assay Pack Calibration Interval on each Atellica IM analyzer from 10 days to 3 days. See Additional Information for instructions on changing the Pack Calibration Interval. All Atellica IM BR assay kit lots can continue to be utilized with the updated Pack Calibration Interval of 3 days. Continue to follow the Atellica IM BR IFU claimed 28-day On-board Stability and 32-day Lot Calibration Intervals. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Additional Information Instructions for Changing the Pack Calibration Interval on Atellica IM Analyzers Instructions for updating the BR Pack Calibration Interval from 10 days to 3 days on each Atellica IM analyzer are outlined below. 1) Sign into Atellica IM analyzer as Labmanager user level 2) In the Worklist Overview screen, move all BR results to Historical 3) In the Setup screen, select Test Definition, select IM Test Definition, and select BR Test 4) Select the Calibration Tab 5) Under Pack C
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026