Siemens Healthcare Diagnostics, Inc. Recall 95118
Description: Atellica IM CA 19-9 (50 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: 10995490
Siemens Healthcare Diagnostics, Inc. Recall 95118 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-3100-2024 |
| Event ID | 95118 |
| Event Description | Atellica IM CA 19-9 (50 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: 10995490 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution |
| Recall 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. |
| Device Classification | 20240918 |
| Device Code Info | UDI-DI: (01)00630414598178(10)55974535(17)20240914 Kit Lot: 55974535, 55975535 |
| Center Classification Date | 20240911 |
| Recall Initiation Date | 20240726 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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