Z-3047-2026Class II

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

Name: Z-3047-2026 STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative...
Creator: Diagnostica Stago, Inc.
Published: 2026-07-29
License: https://open.fda.gov/license/

Diagnostica Stago, Inc. / initiated 2026-07-29 / Open, Classified

FDA source

Diagnostica Stago, Inc. began a recall of STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test on 2026-07-29. The reason FDA records is "A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3047-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-08-28
Recalling firm: Diagnostica Stago, Inc.
Product: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
FDA root cause: Under Investigation by firm
Action: Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following: "Actions Required To prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you: " Immediately discontinue use of STA-Staclot Protein S, Lot 273074. " Dispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations. " Complete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification. Stago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form." For questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.
Quantity in commerce: 5220 units
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.
Product codes and lots: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3047-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3047-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-28

Product code GGP

K913424Class IIStaclot(r) Protein S Test KitAmerican Bioproducts Co. / cleared 1991-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)