Food, drugs, devices › Diagnostica Stago, Inc.

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

FDA enforcement event 99531 · Class II · initiated 29 Jul 2026 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordParsippany, NJ

Diagnostica Stago, Inc. (Parsippany, NJ) initiated this device recall on 29 Jul 2026; FDA lists 1 product record under event 99531, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Diagnostica Stago, Inc. has 16 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Diagnostica Stago, Inc., Parsippany, NJ.

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."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-3047-2026	STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test	5220 units	Class II	Ongoing	9 Sep 2026

Context

87%of 2026 device events are Class II572 events that year

1product record in this eventfirm median: 1

16events on this register for the firm

Other enforcement events for Diagnostica Stago, Inc.

Initiated	Product (first record)	Type	Class	Records
5 Feb 2026	Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitr	Device	Class II	1
4 Feb 2026	Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Produc	Device	Class II	1
15 Dec 2025	Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in pla	Device	Class II	1
12 Sep 2025	Product: STA Liatest D-Di; REF: 00515;	Device	Class II	1
21 Jul 2025	STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop anal	Device	Class II	4
21 May 2025	STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent fo	Device	Class II	1
22 Mar 2023	STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59	Device	Class II	3
4 Mar 2020	STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in t	Device	Class II	1
18 Nov 2019	STA UNICALIBRATOR (ref. 00675)	Device	Class II	2
14 Nov 2018	Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative de	Device	Class II	2

All 16 events for Diagnostica Stago, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.