Siemens Healthcare Diagnostics, Inc.: Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Hazard

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.

Details from the source

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. Quantity: 1,625 units (1450 US, 175 OUS) Lot/code info: Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;

UPC codes

00630414595771

Source

Official record: FDA (Device enforcement) ↗

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