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U.S. Department of Health and Human Services

Class 2 Device Recall HDL Cholesterol Reagent

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  Class 2 Device Recall HDL Cholesterol Reagent see related information
Date Initiated by Firm September 18, 2006
Date Posted November 14, 2006
Recall Status1 Terminated 3 on June 06, 2007
Recall Number Z-0076-2007
Recall Event ID 36436
510(K)Number K992002  
Product Classification in vitro diagnostic - Product Code LBR
Product Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX.
Code Information Control #05291; kit contains Lot #23651 and Lot #23652; (Pointe Scientific Lot #523002).
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
Action Firm notified consignees via letter on 09/20/06.
Quantity in Commerce 9 test kits.
Distribution Worldwide, including USA, Korea, Thailand, Venezuela and Mexico.
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 = LBR and Original Applicant = POINTE SCIENTIFIC, INC.
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