Recall Z-2666-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-2666-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-08

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests). Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-08-08
Firm location: Tarrytown, NY, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.