Orasure Technologies Inc.

Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.

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

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.

Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

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.

Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box