Recall Z-1159-2008 ยท LKJ Antinuclear Antibody, Antigen, Control
Bio-Rad Laboratories
BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is used as an aid in the diagnosis of systemic autoimmune diseases.
| 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 | 8,804 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
| K043341 | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories, Inc., Oct 27, 2005 |