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

Medical DevicesSource: FDA (device) · Date: 2026-09-09

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Diagnostica Stago, Inc.
Product
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Reason / hazard
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-07-29
Code info
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Product quantity
5220 units
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
99531
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