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FDAFDA · Food and drugs·Recall number Z-3047-2026

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

Published September 9, 2026 · Recall initiated: July 29, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Diagnostica Stago, Inc.
Distributor
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.
Lot
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Risk classification
Class II
Area (FDA)
device
Country
United States

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