Class 3 Device Recall Rubella IgG EIA test kit

• Date Initiated by Firm: August 20, 2008
• Date Posted: March 02, 2010
• Recall Status: Terminated 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: 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