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.
This recall has been terminated (originally issued November 23, 2010).
- Company
- Bio-Rad Laboratories
- Recall Initiated
- November 23, 2010
- Terminated
- August 4, 2011
- Recall Number
- Z-1650-2011
- Quantity
- 202
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
Reason for Recall
An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
Distribution
Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy.
Lot / Code Info
Catalog #: 663-1430 Lot #: 46636
Root Cause
Other
Action Taken
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.