| Date Initiated by Firm | July 18, 2006 |
|---|
| Date Posted | August 26, 2006 |
|---|
| Recall Status1 |
Terminated 3 on November 06, 2006 |
| Recall Number | Z-1441-06 |
|---|
| Recall Event ID |
35946 |
| 510(K)Number | K923731 |
|---|
| Product Classification |
LA Assay - Product Code GFO
|
| Product | Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. |
|---|
| Code Information |
Lot 050947D --exp. April 2007; Lot 051527A -- exp. June 2007; Lot 051527B -- exp. June 2007; Lot 051527C -- exp. June 2007; Lot 051527D -- exp. June 2007. |
Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
| For Additional Information Contact | Laura Wofolk, PhD.
973-631-1200 |
|---|
Manufacturer Reason
for Recall | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall notification letters were sent out via first class mail on July 18, 2006. |
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| Quantity in Commerce | 4,365 kits |
|---|
| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = GFO
|
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