Z-3101-2024Class II

Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9...

Name: Z-3101-2024 Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-07-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-26 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the... on 2024-07-26. FDA classified it as Class II and gives the reason as "Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3101-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-26
Posted: 2024-09-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489
Product code: NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Reason for recall: Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
FDA root cause: Under Investigation by firm
Action: Siemens has issued an Urgent Medical Device Correction (UMDC) AIMC 24-14.A.US to US customers, and an Urgent Field Safety Notice (UFSN) AIMC 24-14.A.OUS to Outside the US (OUS) customers on 7/26/24. Letter states reason for recall, health risk and action to take: " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " Perform the instructions provided below: o Discontinue use of and discard the kit lots listed in the table above (Products Section). o If you experience this issue, you may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. o Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. o Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution CA 19-9 kit lots ending in 535 are not available for purchase or use. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Distribution: Worldwide - US Nationwide distribution
Product codes and lots: UDI-DI: (01)00630414598161(10)55977535(17)20240914 Kit Lot: 55977535

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3101-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3100-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3101-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3102-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3103-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-3104-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11

Product code NIG

K031393Class IIBayer Advia Centaur Ca 19-9 AssayBayer Healthcare, LLC / cleared 2003-06-24

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)