Recall Z-1650-2011 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Laboratories
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.
| Date | Nov 23, 2010 |
| Status | Terminated |
| Reason | An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges. |
| Root cause | 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 R |
| Quantity | 202 |
| Distribution | Worldwide distribution: USA and countries including: Canada, Czech Republic, France, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063866 | BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories, Mar 19, 2007 |