Recall Z-3047-2026— Diagnostica Stago, Inc.

Name: FDA recall Z-3047-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-29

Class II · Ongoing

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2026-07-29. It names one FDA 510(k) clearance: K913424. Product: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test. Reason: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified.

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-29
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K913424 — STACLOT(R) PROTEIN S TEST KITAmerican Bioproducts Co.·cleared 1991-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.