FDA Enforcement
Class II
Ongoing
Atellica IM CA 19-9 (250 Test - REF)-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: 11206239
Recall: Z-3102-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3102-2024
- Event ID
- 95118
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2024
- Initiation Date
- July 26, 2024
- Classification Date
- September 11, 2024
- Address
- 333 Coney St, East Walpole, MA, 02032-1516, United States
Description
Atellica IM CA 19-9 (250 Test - REF)-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: 11206239
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.
Code Info
UDI-DI: (01)00630414293516(10)56434535(17)20240914 Kit Lot: 56434535
Distribution
Worldwide - US Nationwide distribution