Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
FDA device recall Z-1441-06 · posted 2006-08-26 · Terminated
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
- Action taken
- Recall notification letters were sent out via first class mail on July 18, 2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GFO
- Quantity affected
- 4,365 kits
- Distribution
- Nationwide
- Date initiated
- 2006-07-18
- Date posted
- 2006-08-26
- Date terminated
- 2006-11-06
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STACLOT LA TEST KIT (K923731) | American Bioproducts Co. | 1992-12-23 |