Z-1331-2015Class I

Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

Name: Z-1331-2015 Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
Creator: Lusys Laboratories, Inc.
Published: 2015-03-13
License: https://open.fda.gov/license/

Lusys Laboratories, Inc. / initiated 2015-03-13 / Terminated

FDA source

Lusys Laboratories, Inc. began a recall of Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit on 2015-03-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1331-2015
Classification: Class I
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-04-09
Terminated: 2017-05-31
Recalling firm: Lusys Laboratories, Inc.
Product: Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
Product code: N/A
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.
FDA root cause: No Marketing Application
Action: LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688. For questions regarding this recall call 858-546-0902.
Quantity in commerce: 40 units
Distribution: Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Product codes and lots: Lot No. 12012014A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1331-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1329-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1330-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1331-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1332-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1333-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1334-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09
Z-1335-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-15	2015-04-09

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)