FDA recall Z-2027-2025

Product

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Reason for recall

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.

Key facts

Status

Ongoing

Initiation date

2025-05-22

Report date

2025-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2027-2025