FDA recall Z-3047-2026

Diagnostica Stago, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2026-07-29
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3047-2026