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

Ebola Virus Gp-vp IgS recalled by Lusys Laboratories

Lusys Laboratories is recalling Ebola Virus Gp-vp IgS, distributed nationwide in the US. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesn/a

Quantity recalled40 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-1335-2015
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: Other Reasons
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.

Product as listed by the FDA

Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

Where it was distributed

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

Nationwide California

Questions about this recall

Is Ebola Virus Gp-vp IgS recalled?

Yes. Lusys Laboratories recalled Ebola Virus Gp-vp IgS on 13 Mar 2015. The recall is Class I and its status is Terminated. Recall number Z-1335-2015.

Why was it recalled?

Which lots are affected?

n/a

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

More recalls from Lusys Laboratories

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