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Class IIOngoing

Diagnostica Stago, Inc. recalls STA Staclot Protein S

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Diagnostica Stago, Inc.
Reason
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99531…

Products

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

    Codes/lots: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027Quantity: 5220 unitsRecall no. Z-3047-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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