Z-2403-2016Class I

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens...

Name: Z-2403-2016 OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens...
Creator: OraSure Technologies, Inc.
Published: 2016-07-20
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2016-07-20 / Terminated / root cause: manufacturing process

FDA source

OraSure Technologies, Inc. began a recall of OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses on 2016-07-20. FDA classified it as Class I and gives the reason as "Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2403-2016
Classification: Class I
Status: Terminated
Initiated: 2016-07-20
Posted: 2016-08-17
Terminated: 2017-05-10
Recalling firm: OraSure Technologies, Inc.
Product: OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Reason for recall: Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: OraSure contacted the sole customer via email and mail (letter dated July 21, 2016) to request return of all the product from the affected lot.
Quantity in commerce: 3,075 units
Distribution: Distributed to one customer only in US state of Georgia.
Product codes and lots: Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2403-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2403-2016	Class I	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-17

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)