Recall Z-0479-2009 ยท LDJ Enzyme Immunoassay, Cannabinoids
OraSure Technologies, Inc.
Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.
| Date | Dec 23, 2008 (initiated Sep 8, 2008) |
| Status | Terminated |
| Reason | Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002375 | STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I OraSure Technologies, Inc., Jan 26, 2001 |