FDAFDA · Food and drugs·Recall number Z-3103-2024
ADVIA Centaur 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: 10491379 SMN: 11206239
Published September 18, 2024 · Recall initiated: July 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide - US Nationwide distribution
- Lot
- UDI-DI: (01)00630414574257(10)55970535(17)20240914; (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535, 55971535
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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