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 HDL Cholesterol 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 HDL Cholesterol Reagentsee related information
Date Initiated by FirmSeptember 18, 2006
Date PostedNovember 14, 2006
Recall Status1 Terminated 3 on June 06, 2007
Recall NumberZ-0074-2007
Recall Event ID 36436
510(K)NumberK992002 
Product Classification in vitro diagnostic - Product Code LBR
ProductStanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.
Code Information Control #05276CE; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002).
FEI Number 1616487
Recalling Firm/
Manufacturer		 Stanbio Laboratory, Inc
1261 N Main St
Boerne TX 78006-3014
Manufacturer Reason
for Recall		Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA Determined
Cause 2		Other
ActionFirm notified consignees via letter on 09/20/06.
Quantity in Commerce47 test kits.
DistributionWorldwide, including USA, Korea, Thailand, Venezuela and Mexico.
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 = LBR
-
-