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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 13, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall Number Z-1419-05
Recall Event ID 32494
510(K)Number K921684  
Product Classification Test, Time, Partial Thromboplastin - Product Code GGW
Product PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054.
Code Information Cat. No. 00599 Lot Number 041755 exp. 06/06.
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information Contact James Barrow
800-222-2624 Ext. 116
Manufacturer Reason
for Recall		 Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
FDA Determined
Cause 2		 Other
Action On 4/13/2005, recall notification letters were sent to all customers and instructed them to stop using the kits and to dispose of the kits according to local regulations.
Quantity in Commerce 740 kits
Distribution The firm distributed this product to 32 clinics/laboratories/hospitals 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 = GGW and Original Applicant = AMERICAN BIOPRODUCTS CO.
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