FDAClass II · Medical device · Recall Z-3047-2026 · Recalled September 9, 2026

STA Staclot Protein S recall — Diagnostica Stago, Inc.

Agency report date: September 9, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: STA Staclot Protein S
Company / brand: Diagnostica Stago
Lot / serial / date codes: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Distribution: 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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: STA Staclot Protein S recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3047-2026
Brand: All Diagnostica Stago recalls
Classification: Class II
Units affected: 5220 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

STA Staclot Protein S recall status

Companies & origin

Recalling firm location: Parsippany, NJ, United States
Firm address: 5 Century Dr, N/A, 07054-4607

Identifying details (verbatim from the notice)

Product codes / lots: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Distribution: 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.
Firm notified the public via: E-Mail
FDA event ID: 99531
Recall initiated: July 29, 2026
FDA classified: August 28, 2026
FDA report date: September 9, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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