Recall archive / FDA device enforcement
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test) — FDA record Z-3305-2024
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 Aug 21, 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 aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- Reason
- Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 9783 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3305-2024
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: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide.
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
- Oct 9, 2024
- Recall initiation date
- Aug 21, 2024
- Center classification date
- Sep 27, 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.