ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use ... (Siemens Healthcare Diagnostics, Inc.) – positive bias for some samples around... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ADVIA Centaur 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: 10491244
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: (01)00630414574028(10)55972535(17)20240914, (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535
Products Sold
UDI-DI: (01)00630414574028(10)55972535(17)20240914; (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535, 55973535
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 1 due to 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 greate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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