Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit.
This recall has been terminated (originally issued December 23, 2008).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- September 8, 2008
- Posted
- December 23, 2008
- Terminated
- May 5, 2009
- Recall Number
- Z-0478-2009
- Quantity
- 2198 units
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Product Number 61452. Lot numbers 6604827, 6604834, 6606583, 5506589, and 6606034
Root 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.
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