Class 2 Device Recall STA Staclot Protein S

• Date Initiated by Firm: July 29, 2026
• Date Posted: August 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3047-2026
• Recall Event ID: 99531
• 510(K)Number: K913424
• Product Classification: Test, qualitative and quantitative factor deficiency - Product Code GGP
• Product: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
• Code Information: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
• FEI Number: 2245451
• Recalling Firm/ Manufacturer: Diagnostica Stago, Inc.; 5 Century Dr; Parsippany NJ 07054-4607
• For Additional Information Contact: Technical Hotline; 800-7250607
• Manufacturer Reason for Recall: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GGP