medical MODERATE Updated 2026-09-09

Diagnostica Stago, Inc. recalls STA Staclot Protein S, Model/Catalog Number: 00746-Reagent L

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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