Recall Z-0477-2009
OraSure Technologies, Inc. · initiated September 8, 2008
Product
Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.
Codes / lots: Product number 61456. Lot numbers 6604829, 6604836, 6606036, 6606585, and 6606591
Reason for recall
Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm issued a letter entitled "URGENT PRODUCT RECALL NOTICE" dated 9/8/08 to their customers to inform them of the problem and the need to return the product.
Details
- Recall number
- Z-0477-2009
- Initiated
- September 8, 2008
- Posted by FDA
- December 23, 2008
- Terminated
- May 5, 2009
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Quantity
- 2198 units
- Distribution
- Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0478-2009 | Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | 09/08/2008Terminated |
| Z-0479-2009 | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro…Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information… | 09/08/2008Terminated |