Reported Sep 9, 2026 · Ongoing · Updated Sep 14, 2026

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

Diagnostica Stago, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607

Is this the product you have?

  • STA Staclot Protein S
  • Model/Catalog Number00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Lot codes and dates
  • UDI(01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Amount recalled
5220 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 2:46 PM UTC

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