Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzym
FDA device recall Z-1383-2008 · posted 2008-03-31 · Terminated
Recall details
- Recalling firm
- Nanosphere, Inc.
- Reason for recall
- Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
- Action taken
- Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.
- Root cause
- Other
- Status
- Terminated
- Product code
- ODW
- Quantity affected
- 624 units
- Distribution
- Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
- Date initiated
- 2008-02-25
- Date posted
- 2008-03-31
- Date terminated
- 2010-05-17
- Location
- Northbrook, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST (K070804) | Nanosphere, Inc. | 2007-09-17 |