Recall archive / FDA device enforcement
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associat... — FDA record Z-3101-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3101-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (01)00630414598161(10)55977535(17)20240914 Kit Lot: 55977535 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Jul 26, 2024
- Center classification date
- Sep 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.