CLASS I Device recall · Reported 15 Apr 2015 · FDA Enforcement Report

Ebola Accessories assembled, self-contained package recalled

Lusys Laboratories is recalling Ebola Accessories assembled, self-contained package, distributed in California. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot No. DEI007963

Quantity recalled20 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1332-2015
FDA event ID: 70668
Recalling firm: Lusys Laboratories, San Diego, CA
Classification: Class I
Status: Terminated
Recall initiated: 13 Mar 2015
FDA classified: 9 Apr 2015
Reported: 15 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

13 Mar 2015	Recall initiated by company
9 Apr 2015	Classified by FDA	+27 days
15 Apr 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

Where it was distributed

Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

California

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot No. DEI007963

Where was it sold?

Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 70668

This product is part of a recall event; the main page for the event is Ebola GP IgX Blood, Serum, Plasma, Cassette recalled.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2015	CLASS I	Ebola GP IgX Blood, Serum, Plasma, Cassette recalled	Lusys Laboratories	Packaging Defects	CA
15 Apr 2015	CLASS I	Ebola Virus Antigen Blood recalled by Lusys Laboratories	Lusys Laboratories	Other	CA
15 Apr 2015	CLASS I	Ebola Virus Gp-vp IgS recalled by Lusys Laboratories	Lusys Laboratories	Other	CA
15 Apr 2015	CLASS I	Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Packaging Defects	CA
15 Apr 2015	CLASS I	Ebola Virus Antigen Nasal recalled by Lusys Laboratories	Lusys Laboratories	Other	CA
15 Apr 2015	CLASS I	Ebola IgX VP-40 Serum/Plasma/Blood Cassette recalled	Lusys Laboratories	Other	CA
15 Apr 2015	CLASS I	Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Other	CA

More recalls from Lusys Laboratories

All 11

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Device	CLASS I	Covid-19 IgG/Igm Antibody Test For Detection of Covid recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	LuSys 2nd Generation of Covid-19 Viral Antigen Test For all recalled	Lusys Laboratories	Other	Nationwide
16 Mar 2022Device	CLASS I	Luscient Diagnostics 2nd Generation of Covid-19 Viral recalled	Lusys Laboratories	Other	Nationwide
15 Apr 2015Device	CLASS I	Ebola GP IgM Blood (Blood Serum/Plasma/Cassette) recalled	Lusys Laboratories	Other	CA
15 Apr 2015Device	CLASS I	Ebola IgX VP-40 Serum/Plasma/Blood Cassette recalled	Lusys Laboratories	Other	CA

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