ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated
FDA device recall Z-3104-2024 · posted 2024-09-11 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NIG
- Distribution
- Worldwide - US Nationwide distribution
- Date initiated
- 2024-07-26
- Date posted
- 2024-09-11
- Location
- East Walpole, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393) | Bayer Healthcare, LLC | 2003-06-24 |