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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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."
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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