Food, drugs, devices › Diagnostica Stago, Inc.

Device recall: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact

FDA enforcement event 69070 · Class III · initiated 18 Jul 2014 · status Terminated · terminated 16 Jan 2015

DeviceVoluntary: Firm initiated1 product recordParsippany, NJ

FDA enforcement event 69070 is a device recall by Diagnostica Stago, Inc. of Parsippany, NJ, initiated 18 Jul 2014 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 16 Jan 2015. 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

"Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers."

Distribution

"Distributed USA (nationwide) and the country of Canada."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2650-2014	Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on…	514 kits	Class III	Terminated	24 Sep 2014

Context

4%of 2014 device events are Class III1,176 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
29 Jul 2026	STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor defici	Device	Class II	1
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

All 16 events for Diagnostica Stago, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed USA (nationwide) and the country of Canada."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 16 Jan 2015. "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.