Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2666-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

Product Classification:

Class II

Date Initiated: August 8, 2023

Date Posted: October 11, 2023

Recall Number: Z-2666-2023

Event ID: 92971

Reason for Recall:

There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.

Status: Ongoing

Product Quantity: 4966 reagents

Code Information:

(6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821

Distribution Pattern:

US Nationwide. Global Distribution

Voluntary or Mandated:

Voluntary: Firm initiated