Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit.
FDA device recall Z-0477-2009 · posted 2008-12-23 · Terminated
Recall details
- Recalling firm
- OraSure Technologies, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LDJ
- Quantity affected
- 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.
- Date initiated
- 2008-09-08
- Date posted
- 2008-12-23
- Date terminated
- 2009-05-05
- Location
- Bethlehem, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I (K002375) | OraSure Technologies, Inc. | 2001-01-26 |