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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 Syphilis IgG Control Set

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  Class 2 Device Recall BioPlex 2200 Syphilis IgG Control Set see related information
Date Initiated by Firm November 23, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-1650-2011
Recall Event ID 57404
510(K)Number K063866  
Product Classification Enzyme linked immunoabsorption assay, treponema, pallidum - Product Code LIP
Product BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636

The BioPlex 2200 Syphilis IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis IgG Reagent Pack in the clinical laboratory.
Code Information Catalog #: 663-1430 Lot #: 46636
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		 An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
FDA Determined
Cause 2		 Other
Action The firm, Bio-Rad, sent a "Voluntary Field Correction: QC Ranges for Syphilis IgG Control Set Lot#46636" letter to Domestic customers via FedEx on November 24, 2010 and to the International customers via e-mail on November 23, 2010. The letter described the product, problem and actions to be taken by customers. The Customers were advised to temporarily establish their own means and acceptable ranges for Control Lot 46636 for the r15 and r47 markers. The firm will provide adjusted recommended means and acceptable ranges. Additionally, the customers were to complete and return the Customer Response Form for USA and/or the Subsidiary Response Form (Outside US) via fax to (510) 741-4846, Attn: Bio-Rad BPD-Product Support. If you have any questions about this notification, contact your local Bio-Rad Technical Support.
Quantity in Commerce 202
Distribution Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
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 = LIP and Original Applicant = Bio-Rad Laboratories
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