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U.S. Department of Health and Human Services

Class 3 Device Recall Micro Plate EIA Oral Fluid Cutoff Calibrator

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  Class 3 Device Recall Micro Plate EIA Oral Fluid Cutoff Calibrator see related information
Date Initiated by Firm September 08, 2008
Date Posted December 23, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall Number Z-0479-2009
Recall Event ID 49557
510(K)Number K002375  
Product Classification Cannabinoid Test System - Product Code LDJ
Product Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
Code Information Product number 61454. Lot number 6604282, 6604835, 6606584, 6606590, and 6606035
Recalling Firm/
Manufacturer		 OraSure Technologies, Inc.
1745 Eaton Ave
Bethlehem PA 18018-1769
For Additional Information Contact Jackie Ferro
610-882-1820
Manufacturer 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 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LDJ and Original Applicant = ORASURE TECHNOLOGIES, INC.
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