Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)

Hazard

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.

Details from the source

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. Distribution: US Nationwide. Global Distribution Quantity: 4966 reagents Lot/code info: (6 x 350 tests) UDI-DI: 00630414561974; (7 x 145 tests) UDI-DI: 00630414513157; Lot Numbers: 612584 625096 612579 625091 635826 635821

UPC codes

00630414561974, 00630414513157

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.