Reported Aug 24, 2016 · Terminated
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola…
OraSure Technologies, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OraSure Technologies, Inc. · 1745 Eaton Ave · Bethlehem, PA · 18018-1769
Is this the product you have?
- OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
- Lot codes and dates
- Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
- Amount recalled
- 3,075 units
Where it was sold
Why it was recalled
Stop using this product now
Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Using this product could cause serious injury, illness or death — stop using it now.
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