Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3100-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Atellica IM 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: 10995490

Product Classification:

Class II

Date Initiated: July 26, 2024

Date Posted: September 18, 2024

Recall Number: Z-3100-2024

Event ID: 95118

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.

Status: Ongoing

Product Quantity:

Code Information:

UDI-DI: (01)00630414598178(10)55974535(17)20240914 Kit Lot: 55974535, 55975535

Distribution Pattern:

Worldwide - US Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated