Reported Apr 27, 2016 · Terminated
OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with…
OraSure Technologies, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
- Lot codes and dates
Item Number 1001-0343Lot # 6648737
- Amount recalled
- 244 Visual Reference Panel Kits
Where it was sold
Why it was recalled
OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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