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.
FDA Recall Z-1650-2011 · Posted None
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Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeLIP
Date Initiated2010-11-23
Date Terminated2011-08-04
Product Quantity202
Reason for Recall
An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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