Z-2426-2021Class II

Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial...

Name: Z-2426-2021 Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial...
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2021-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-07-06 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of 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... on 2021-07-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2426-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-06
Posted: 2021-09-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: MOI System, Test, Immunological, Antigen, Tumor
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 787 units
Distribution: Worldwide distribution. US Nationwide, Australia, Bahamas, India, Mexico, Saudi Arabia, and Viet Nam
Product codes and lots: All lots impacted Kit lot numbers: 41331255 & 74682255 expiration date 2021-08-03, Lot number: 91605257 expiration date 2021-11-10.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2426-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2424-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-03
Z-2425-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-03
Z-2426-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-03

Product code MOI

K982680Class IIChiron Diagnostics Corporation Acs: Centaur Br ImmunoassayChiron Diagnostics Corp. / cleared 1998-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)