Class II

Medical Device Recall: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test

Diagnostica Stago, Inc. · July 29, 2026

Reason for Recall

A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified

Distribution

US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.

States Affected

NATIONWIDE

Quantity Affected

5220 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3047-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Diagnostica Stago, Inc. Medical Device Recall: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test | SafeCheck