Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2403-2016

July 20, 2016

Class I

Product summary

Firm
OraSure Technologies, Inc.
Event
Event 74843
Status
Terminated
Classification
Class I
Quantity
3,075 units
Official record key
device-enforcement:Z-2403-2016

Official wording

Reason: Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.