Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
FDA Recall Z-0479-2009 · Posted 2008-12-23
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Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeLDJ
Date Initiated2008-09-08
Date Terminated2009-05-05
Product Quantity2198 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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