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
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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. |
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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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