Recall Z-0256-2008 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Labroatories Inc.
BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD
| Date | Nov 9, 2007 (initiated Sep 25, 2007) |
| Status | Terminated |
| Reason | Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive) |
| Root cause | Labeling Change Control |
| Action | The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date. |
| Quantity | 36 |
| Distribution | Nationwide |
| 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 |