Z-3101-2024 Class II Ongoing
FDA device recall Z-3101-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Jul 26, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jul 26, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
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.
Distribution Pattern
Worldwide - US Nationwide distribution
Code Information
UDI-DI: (01)00630414598161(10)55977535(17)20240914 Kit Lot: 55977535
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3101-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026