Recall Z-1156-2008 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Laboratories
BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum.
| Date | Jun 11, 2008 (initiated Nov 13, 2007) |
| Status | Terminated |
| Reason | False negative results due to reagent packs exhibiting low signal. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/13/2007, the firm faxed Voluntary Field Correction Letters (which are dated 11/9/2007) to its consignees and also contacted them via telephone. The Voluntary Field Correction Letters: a) informed them of the potential for false negative results; b) recommended that they perform QC testing daily with each reagent pack; c) provided a new insert for the Instructions for Use; and d) provided a Response Sheet for each consignee to complete and return to the firm. |
| Quantity | 796 kits |
| Distribution | Worldwide Distribution -- USA, Canada, France, United Kingdom, Italy, Germany, South Africa, and Switzerland. |
| 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 |