OraSure Technologies, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2403-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: July 20, 2016

Date Posted: August 24, 2016

Recall Number: Z-2403-2016

Event ID: 74843

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.

Status: Terminated

Product Quantity: 3,075 units

Code Information:

Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

Distribution Pattern:

Distributed to one customer only in US state of Georgia.

Voluntary or Mandated:

Voluntary: Firm initiated