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 Dade Actin FS Activated PTT Reagent

  • 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 Recall Dade Actin FS Activated PTT Reagentsee related information
Date Initiated by FirmSeptember 23, 2005
Date PostedDecember 23, 2005
Recall Status1 Terminated 3 on May 11, 2006
Recall NumberZ-0304-06
Recall Event ID 33800
510(K)NumberK811589 
Product Classification Test, Time, Partial Thromboplastin - Product Code GGW
ProductDade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
Code Information Lot number 527263 exp 2/3/06
FEI Number 2517506
Recalling Firm/
Manufacturer		 Dade Behring , Inc.
500 GBC Dr., Mailstop 514
PO BOX 6101
Newark DE 19714-6101
For Additional Information ContactAydee Crawford
302-631-6312
Manufacturer Reason
for Recall		prolonged aPTT results
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
Quantity in Commerce4176 packs
DistributionThe products were shipped to medical facilities and/or laboratories 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
-
-