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U.S. Department of Health and Human Services

Class 3 Device Recall Rubella IgG EIA test kit

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  Class 3 Device Recall Rubella IgG EIA test kit see related information
Date Initiated by Firm August 20, 2008
Date Posted March 02, 2010
Recall Status1 Terminated 3 on April 08, 2010
Recall Number Z-0908-2010
Recall Event ID 49449
510(K)Number K961053  
Product Classification enzyme linked immunoabsorbent assay, rubella - Product Code LFX
Product Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052

For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
Code Information Lot F1108
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact
425-498-1709
Manufacturer Reason
for Recall		 Elevated optical density (OD) values with the kit Negative Control.
FDA Determined
Cause 2		 Employee error
Action An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 then 4.
Quantity in Commerce 82 kits
Distribution Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
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 = LFX and Original Applicant = QUEST INTL., INC.
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