Cannabinoids Intercept Micro Plate EIA 100 plate kit
FDA device recall Z-0481-2009 · posted 2008-12-18 · Terminated
Recall details
- Recalling firm
- OraSure Technologies, Inc.
- Reason for recall
- Readings, high: intermittent high absorbance readings. For further information, please contact the firm at 610-882-1820.
- Action taken
- On 9/8/08, the recalling firm telephoned the customer to inform them of the problem. As a follow up to the telephone call, the recalling firm issued a recall letter dated 9/11/08 to the customer.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDJ
- Quantity affected
- 1 kit
- Distribution
- The product was shipped to one customer in New York.
- Date initiated
- 2008-09-08
- Date posted
- 2008-12-18
- Date terminated
- 2008-12-18
- 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 |