FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

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Products

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Brand
OraSure Technologies, Inc.
UPC
Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.

Units Affected

3,075 units

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