Recall Z-1441-06 ยท GFO Activated Partial Thromboplastin
Diagnostica Stago, Inc.
Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay.
| Date | Aug 26, 2006 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
| Root cause | Other |
| Action | Recall notification letters were sent out via first class mail on July 18, 2006. |
| Quantity | 4,365 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923731 | STACLOT LA TEST KIT American Bioproducts Co., Dec 23, 1992 |