Device recall: Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative…

Class II FDA enforcement event 81678. Recall start date: 14 Nov 2018. Status in the FDA record: Terminated. Termination date: 8 Jun 2020.

Reason for recall, in the words of FDA

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

Class II, in the words of FDA

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

Diagnostica Stago, Inc. started this device recall on 14 Nov 2018. The firm address in the FDA record is in Parsippany, NJ. FDA put the recall in Class II. FDA event 81678 has 2 product records. The first FDA enforcement report date is 26 Dec 2018. The record gives the status Terminated, with the termination date 8 Jun 2020.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide Distribution

Recalling firm

Diagnostica Stago, Inc., Parsippany, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 81678: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0610-2019	Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).	22342 total	Class II	Terminated	26 Dec 2018
Z-0611-2019	Staclot LA 20 (REF 00594) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).	22342 total	Class II	Terminated	26 Dec 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 16

Other events of the firm

Other FDA enforcement events of 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

Diagnostica Stago, Inc.: all 16 events

Official channels

FDA enforcement report Z-0610-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 81678. https://recallregister.com/fda/ii/81678/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide Distribution
What quantity of product is in FDA event 81678?: The event has 2 product records. The first record gives this quantity: 22342 total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.