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FDA · Medical devices ·

STA Staclot Protein S, Model/Catalog Number recall

Diagnostica Stago, Inc. recalled STA Staclot Protein S, Model/Catalog Number on September 9, 2026 because of a positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 5220 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Diagnostica Stago, Inc., Parsippany, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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.
Status
Ongoing
Recall number
Z-3047-2026
Source
U.S. Food and Drug Administration

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