Recall Z-0908-2010 ยท LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Bio-Rad Laboratories
Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to
| Date | Mar 2, 2010 (initiated Aug 20, 2008) |
| Status | Terminated |
| Reason | Elevated optical density (OD) values with the kit Negative Control. |
| Root cause | Employee error |
| Action | An "Urgent Product Correction" letter dated August 26, 2008 was sent via overnight carrier to all customers. The letter described the affected product, problem, and action to be taken by customer. The customers are to review their current inventory of the product for any remaining kits of the specified lot number. The customer is to complete the form and fax to the Technical Support department if replacement kits were needed. The remaining kits will be replaced once the form is completed and faxed. If you have any questions, please contact Technical Support at 1-800-224-6723, options 2 the |
| Quantity | 82 kits |
| Distribution | Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961053 | SERAQUEST RUBELLA IGG Quest Intl., Inc., Sep 4, 1996 |