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U.S. Department of Health and Human Services

Class 1 Device Recall OraQuick Ebola Rapid Antigen Test

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  Class 1 Device Recall OraQuick Ebola Rapid Antigen Test see related information
Date Initiated by Firm July 20, 2016
Date Posted August 17, 2016
Recall Status1 Terminated 3 on May 10, 2017
Recall Number Z-2403-2016
Recall Event ID 74843
Product OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
Code Information Product Code 3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information Contact
610-882-1820 Ext. 5043
Manufacturer Reason
for Recall		 Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 3,075 units
Distribution Distributed to one customer only in US state of Georgia.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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