OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures
OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic test for a serious pathogen (Ebola) where the defect (false negatives) poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
OraSure Technologies, Inc. is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807. The recall is limited to Lot 6648965, which has an expiration date of October 31, 2016. The product is intended for the qualitative detection of antigens for Ebola viruses.
The recall was initiated after the product failed stability testing at 8 months. Specifically, the lot produced intermittent false negative results for the positive kit control when devices were stored at 30C conditions. This defect could compromise the reliability of the test results.
The affected units were distributed to one customer only in the US state of Georgia. Consumers and healthcare providers should stop using the recalled product and contact the manufacturer for further instructions.
The recalled product
- Product
- OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- Manufacturer
- OraSure Technologies, Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 3,075
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2016.
Distribution
Distributed in 1 state:
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