Recall Z-3101-2024 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Siemens Healthcare Diagnostics, Inc.
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
| Date | Sep 11, 2024 (initiated Jul 26, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| 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 |
| Distribution | Worldwide - US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC, Jun 24, 2003 |