Fresh Recalls

STA Staclot Protein S: recall status

Notice names this product. Diagnostica Stago’s STA Staclot Protein S is named in FDA Class II recall Z-3047-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified Identifying details: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027. Units affected: 5220 units. Status: Ongoing.

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.

Brand
Diagnostica Stago

Recalls naming this model

FDA Class II · Medical device · September 9, 2026

STA Staclot Protein S recall — Diagnostica Stago, Inc.

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

Company / brand: Diagnostica Stago recalls

Affected product: STA Staclot Protein S recall status

Official ID Z-3047-2026 · Official record ↗

See all Diagnostica Stago recalls →

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.