FDA recall Z-2666-2023

Product

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.

Distribution

US Nationwide. Global Distribution

Key facts

Status

Ongoing

Initiation date

2023-08-08

Report date

2023-10-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2666-2023