Class IIDeviceOngoing

Diagnostica Stago, Inc.

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

Reason for recall

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

Details

Recall number: Z-3047-2026
Event ID: 99531
Recall initiated: Jul 29, 2026
Classified: Aug 28, 2026
Reported: Sep 9, 2026
Quantity: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Parsippany, NJ, United States
Lot / code info: UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027