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U.S. Department of Health and Human Services

Class 2 Device Recall Staclot LA 20

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  Class 2 Device Recall Staclot LA 20 see related information
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.
Quantity in Commerce 4,365 kits
Distribution Nationwide
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 and Original Applicant = AMERICAN BIOPRODUCTS CO.
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