Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmApril 13, 2005
Date PostedAugust 30, 2005
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-1419-05
Recall Event ID 32494
510(K)NumberK921684 
Product Classification Test, Time, Partial Thromboplastin - Product Code GGW
ProductPTT-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.
FEI Number 2245451
Recalling Firm/
Manufacturer		 Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
For Additional Information ContactJames 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
ActionOn 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 Commerce740 kits
DistributionThe firm distributed this product to 32 clinics/laboratories/hospitals nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GGW
-
-