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FDAMay 22, 2025device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414595771

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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