Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Pr
FDA device recall Z-0594-2007 · posted 2007-03-13 · Terminated
Recall details
- Recalling firm
- Inverness Medical Professional Diagnostics
- Reason for recall
- Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
- Action taken
- Recall notification letters were sent to all customers on 2/14/07 by first class mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 382 kits
- Distribution
- Worldwide, including USA, Puerto Rico, and Canada.
- Date initiated
- 2007-02-15
- Date posted
- 2007-03-13
- Date terminated
- 2007-05-08
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMPLIFY D-DIMER, MODEL DCGK1 (K993276) | Agen Biomedical , Ltd. | 1999-12-14 |